Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) |
Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response) |
Baseline, 16 Weeks |
|
| Primary |
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) |
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) |
Baseline, 16 Weeks |
|
| Primary |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) |
Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response) |
Baseline, 16 Weeks |
|
| Primary |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) |
Baseline, 16 Weeks |
|
| Primary |
Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a restricted maximum likelihood (REML)-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
Baseline, 16 weeks |
|
| Primary |
Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores which is a greater range of standard scores. Test 13, Word Attack, measures skill in applying phonic, structural analysis to the pronunciation of unfamiliar printed words. Each individual test scores range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. Least Square (LS) Mean was analyzed using last observation carried forward (LOCF), fixed-effects analysis of covariate (ANCOVA) models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. Basic Reading Skills is an aggregate measure of sight vocabulary, phonics, and structural analysis. It is a combination of Test 1, Letter-Word Identification, which measures the participant's word identification skills, and Test 13, Word Attack, which measures skill in applying phonic and structural analysis skills to the pronunciation of unfamiliar printed words. It is the average (arithmetic mean) of the tests 1 and 13. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the attention-deficit disorder (ADD). 0-39 equate to, "ADD possible but not likely". 40-54 equate to, "ADD probable but not certain". 55-120 equate to, "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 weeks |
|
| Secondary |
Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 weeks |
|
| Secondary |
Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 weeks |
|
| Secondary |
Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models of with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 weeks |
|
| Secondary |
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 weeks |
|
| Secondary |
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 weeks |
|
| Secondary |
Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for gender, baseline score, and age. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming, Semantic-category) |
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming, Semantic-category) |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Tasks) |
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Tasks) |
From Week 16, Up to 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. |
From Week 16, Up to 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
From Week 16, Up to Week 32 |
|
| Secondary |
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
From Week 16, Up to Week 32 |
|
| Secondary |
The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia |
The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. |
16 Weeks |
|
| Secondary |
The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia. |
The number of participants who experienced one or more TEAEs and who had ADHD and ADHD+Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. |
16 Weeks |
|
| Secondary |
The Number of Participants With TEAE in Participants With Dyslexia |
The number of participants with at least one TEAE and had Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. |
From 16 Weeks Up to Week 32 |
|
| Secondary |
The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia. |
The number of participants who experienced one or more TEAEs with ADHD and ADHD + Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. |
From Week 16 Up to Week 32 |
|
| Secondary |
Number of Participants With Adverse Events |
Number of participants who had at least one adverse event. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. |
32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in GORT-4 in Healthy Participants |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. |
Baseline, 16 weeks |
|
| Secondary |
Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analyses which includes diagnostic group, visit, and diagnostic group-by-visit interaction. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in WMTB-C in Healthy Participants |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, and diagnostic group-by-visit interaction. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction. |
Baseline, 16 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. |
Baseline, 32 weeks |
|
| Secondary |
Change From Baseline to Endpoint in GORT-4 in Healthy Participants |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in WMTB-C in Healthy Participants |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction. |
Baseline, 32 Weeks |
|
| Secondary |
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction. |
Baseline, 32 Weeks |
|
