Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)- A Laboratory Classroom Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904670
• Other study ID #: NWP06-ADD-100
• Secondary ID: B7491007
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2009
• Last updated: May 27, 2014
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: May 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to establish that an optimal dose of Quillivant XR oral suspension would result in a significant reduction in signs and symptoms of ADHD compared to placebo treatment in pediatric patients ages 6-12 years with ADHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Male or female from 6 to 12 years of age at the time of screening, inclusive.

• Diagnosis of ADHD by a Psychiatrist, Psychologist, Developmental Pediatrician, or a Pediatrician meeting diagnostic criteria for ADHD (DSM-IV). A Schedule for Affective Disorders and Schizophrenia for School Age Children (K-SADS)16 was administered on all subjects to assist in diagnostic process.

• A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or greater. An Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) score at screening or baseline greater than or equal to the 90th percentile normative values for gender and age in at least one of the following categories: the hyperactive-impulsive subscale, inattentive subscale or the total score.

• Subject must have been in need of pharmacological treatment for ADHD.

• Subjects taking a medication to control ADHD at the time of screening must have been experiencing suboptimal efficacy, a safety or tolerability issue or in need of a long-acting liquid formulation.

• For subjects taking any daily medication at screening aside from ADHD medication:

parent or legal guardian agreed that there would be no elective changes in subject's medications during the study (10 weeks total).

Exclusion Criteria:

• Excluded comorbid psychiatric diagnoses: DSM-IV Axis I diagnosis (active) other than ADHD, with the exception of Specific Phobias, Learning Disorders, Motor Skills Disorders, Communication Disorders, Oppositional Defiant Disorder, Elimination Disorders, Sleep Disorders, and Adjustment Disorders.

• Clinically significant cognitive impairment as assessed in the clinical judgment of the Investigator. In cases where this was not clear, study staff were permitted to administer a Wechsler Abbreviated Scale of Intelligence (WASI)17 to estimate the intelligence quotient (IQ). Significant cognitive impairment for this protocol was defined as an estimated IQ below 80.

• Subjects with chronic medical illnesses including seizure disorder (excluding a history of febrile seizures), severe hypertension, thyroid disease, structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, glaucoma, Tourette's Disorder, family history of Tourette's Disorder or tics.

• Use of monoamine oxidase inhibitors within 30 days of the screening visit.

• Use of any psychotropic medication (except sedative hypnotics prescribed as a sleep aid at a stable dose for at least 30 days prior to screening, at bedtime only). Use of stimulant medication for control of ADHD at screening was permitted if inclusion criterion number 6 was met.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Quillivant Oral Suspension XR
Oral Suspension 25mg/5mL; 20-60 mg/day
• Placebo
Matching Placebo Oral Suspension 25mg/5mL; 20-60 mg/day
• Placebo
Matching placebo was a solution that was identical in taste and appearance to the Active drug that was used in this study.

Locations

Country	Name	City	State
United States	UC Irvine Child Development Center	Irvine	California
United States	Center for Psychiatry and Behavioral Medicine, Incorporated	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SKAMP Quality of Work Subscale Score Over 12 Hours	SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP quality of work subscale is reported which comprises of 3 items, with a total possible score of 0 to 18; higher score indicates worst impairment.	0.75, 2, 4, 8, 10, 12 hours post-dose	No
Other	SKAMP Compliance Subscale Score Over 12 Hours	SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP compliance subscale is reported which comprises of 2 items, with a total possible score of 0 to 12; higher score indicates worst impairment.	0.75, 2, 4, 8, 10, 12 hours post-dose	No
Primary	Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose	The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.	Hour 4 post-dose	No
Secondary	Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale	Onset and duration is determined using SKAMP combined rating scale at each post-dose time point. Onset of effect is defined as first assessment time showing statistical significance (i.e. p is less than or equal to [=<] 0.05) between NWP06 and placebo and duration of effect is defined as the as last consecutive time-point at which difference is still statistically significant between NWP06 and placebo. SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.	0.75, 2, 8, 10, 12 hours post-dose	No
Secondary	SKAMP Attention Subscale Score Over 12 Hours	SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP attention subscale is reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment.	0.75, 2, 4, 8, 10, 12 hours post-dose	No
Secondary	SKAMP Deportment Subscale Score Over 12 Hours	SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP deportment subscale is reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.	0.75, 2, 4, 8, 10, 12 hours post-dose	No
Secondary	Permanent Product Measure of Performance (PERMP) Score Over 12 Hours	The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10-minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure a participant's performance. The total score range from 0-160 with higher scores indicating better performance.	0.75, 2, 4, 8, 10, 12 hours post-dose	No
Secondary	SKAMP Combined Scores Over 12 Hours	The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.	0.75, 2, 8, 10, 12 hours post-dose	No

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