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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03247556
Other study ID # 812P304
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 20, 2017
Est. completion date February 14, 2019

Study information

Verified date June 2021
Source Supernus Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of high doses of SPN-812 in adolescents (12-17 years old) with ADHD


Description:

This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group study to assess the efficacy and safety of SPN-812 as a monotherapy for the treatment of adolescents 12-17 years old with ADHD.


Recruitment information / eligibility

Status Completed
Enrollment 297
Est. completion date February 14, 2019
Est. primary completion date February 14, 2019
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria: 1. Healthy male or female subjects, 12-17 years of age, inclusive. 2. Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). 3. Attention Deficit/Hyperactivity Disorder Rating Scale-5, Home Version: Adolescent, Investigator Administered and Scored (ADHD-RS-5) score of at least 28. 4. CGI-S score of at least 4 at screening. 5. Weight of at least 35 kg. 6. Free of medication for the treatment of ADHD for at least one week prior to randomization and agreement to remain so throughout the study. 7. Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, vital signs, and electrocardiogram. 8. Written informed consent obtained from the subject's parent or legal representative and informed assent from the subject, if applicable. 9. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose, throughout the study: 1. simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration 2. surgically sterile male partner 3. simultaneous use of male condom and diaphragm with spermicide 4. established hormonal contraceptive Exclusion Criteria: 1. Current diagnosis of major psychiatric disorders. Subjects with Major Depressive Disorder are allowed in the study if the subject is free of episodes both currently and for the last six months. 2. Current diagnosis of major neurological disorders. Subjects with seizures or a history of seizure disorder within the immediate family (siblings, parents), or a history of seizure-like events are excluded from the study. 3. Current diagnosis of significant systemic disease. 4. Evidence of suicidality (defined as either active suicidal plan/intent or active suicidal thoughts, or more than one lifetime suicide attempt) within the six months before Screening or at Screening. 5. BMI greater than 95th percentile for the appropriate age and gender. 6. History of an allergic reaction to viloxazine or related drugs. 7. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in this study. 8. Subjects who received any investigational drug within the longer of 30 days or 5 half-lives prior to Day 1 dosing of SM. 9. Any reason, which, in the opinion of the Investigator, would prevent the subject from participating in the study. 10. Positive drug screen at the Screening Visit. A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening; the subject will be required to discontinue the stimulant for the study, beginning at least one week prior to the Baseline Visit. 11. Pregnancy or refusal to practice abstinence or acceptable birth control during the study (for female subjects of childbearing potential)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Placebo was administered once daily
400mg SPN-812
400mg SPN-812 was administered once daily and compared to Placebo
600mg SPN-812
600mg SPN-812 was administered once daily and compared to Placebo

Locations

Country Name City State
United States Gadolin Research, LLC Beaumont Texas
United States Meridien Research at Florida Clinical Research Center Bradenton Florida
United States Carolina Clinical Trials, Inc. Charleston South Carolina
United States Ericksen Research & Development Clinton Utah
United States MCB Clinical Research Centers, LLC Colorado Springs Colorado
United States iResearch Atlanta Decatur Georgia
United States Bayou City Research Corporation Houston Texas
United States Discovery MM Services Inc. Houston Houston Texas
United States Innovative Clinical Research, Inc Lauderhill Florida
United States Alliance for Wellness dba Alliance for Research Long Beach California
United States Miami Clinical Research Miami Florida
United States IPS Research Oklahoma City Oklahoma
United States Paradigm Research Professionals Oklahoma City Oklahoma
United States APG Research, LLC Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Supernus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (<0) represent a better outcome. Baseline and Week 7 (End of Study)
Secondary Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale The first Key Secondary Endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 7 (End of Study). The CGI-I scale is a single item assessment of how much the patient's illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = "very much improved" and 7 = "very much worse." Successful therapy is indicated by a lower overall score in subsequent testing. Week 7 (End of Study)
Secondary Effect of SPN-812 Assessed by Conners 3 - Parent Short Form (C3PS) The second Key Secondary Endpoint was the change from baseline in the Conners 3rd Edition - Parent Short Form (C3PS) Composite T-score at Week 7 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for the assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3PS is completed by a child's parent/guardian and is comprised of 45 items with subsets of items related to six content scales: inattention, hyperactivity/impulsivity, executive functioning, learning problems, defiance/aggression and peer relations. The parent rates his/her child on the first 43 items of the C3PS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently]) based on past month; the last 2 items are fill-in-the-blank. Raw scores are converted to T-scores. Lower change from baseline T-scores (<0) represent a better outcome. Baseline and Week 7 (End of Study)
Secondary Effect of SPN-812 Assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) The third Key Secondary Endpoint was the change from baseline in the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) Total Average score at Week 7 (End of Study). The WFIRS instrument evaluates ADHD-related functional impairment. The WFIRS-P is completed by the child's parent/guardian and is comprised of 50 items grouped into six domains: Family (10 items), School (10 items, includes learning [4 items] and behavior [6 items]), Life Skills (10 items), Child's Self-Concept (3 items), Social Activities (7 items), and Risky Activities (10 items). The parent/guardian rates each item on a 4-point Likert scale (0-3; where 0=never or not at all to 3= very often or very much) based on their child's behavior past month. A Total Average score was computed by calculating mean rating of all 50 items (ranging from 0 to 3, where a higher value represents more severe functional impairment). Lower change from baseline Total Average scores (<0) represent a better outcome. Baseline and Week 7 (End of Study)
Secondary Effect of SPN-812 Assessed by 50% Responder Rate Per the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) An additional secondary endpoint was the percentage of responders at Week 7 (End of Study). A responder was defined as a subject who had a 50% or greater reduction (improvement) in their change from baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). Values range from 0 to 100%. A higher percentage represents a greater number of responders. Week 7 (End of Study)
Secondary Effect of SPN-812 Assessed by Stress Index for Parents of Adolescents (SIPA) Another secondary endpoint was the change from baseline in the Stress Index for Parents of Adolescents (SIPA) Total score to Week 7 (End of Study). The SIPA is a 112-item screening/diagnostic instrument for parents of adolescents 11-19 years of age that identifies areas of stress in parent-adolescent interactions. Items 1-90 are rated on a 5-point Likert scale (where SD=Strongly Disagree, D=Disagree, NS=Not Sure, A=Agree, and SA=Strongly Agree) and yields a raw score for 3 Domains (Adolescent Domain, Parent Domain, and Adolescent-Parent Domain) that focus on a parent's perception of their child's personality and on the parent's characteristics and behaviors. The sum of the 3 Domain scores yields the Total (Parent Stress) score (range: 90-450; higher total scores indicate higher levels of stress). Lower change from baseline scores (<0) represent a better outcome Baseline and Week 7 (End of Study)
Secondary Effect of SPN-812 Assessed by the Hyperactivity/Impulsivity Subscale and the Inattention Subscale of the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) An additional secondary endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Hyperactivity/Impulsivity subscale score and Inattention subscale score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 DSM-5 symptoms of ADHD, including 9 items for the Hyperactivity/Impulsivity subscale and 9 items for the Inattention subscale. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). Each subscale score is calculated by adding the responses of all respective 9 items (range: 0-27; the higher the subscale score, the more severe the Hyperactivity/Impulsivity or Inattention symptoms). Lower change from baseline subscale scores (<0) represent a better outcome. Baseline and Week 7 (End of Study)
Secondary Effect of SPN-812 Assessed by Conners 3 - Self Report Short Form An additional secondary endpoint was the change from baseline in the Conners 3rd Edition - Self Report Short Form (C3-SRS) Composite T score at Week 7 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3-SRS, which is only validated in children/adolescents 8-18 years of age, is comprised of 41 items with subsets of items related to five content scales: inattention, hyperactivity/impulsivity, learning problems, aggression and family relations. The subject rates himself/herself on the first 39 items of C3-SRS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently] based on past month; the last 2 items are fill-in-the-blank and do not contribute to the raw score(s). Raw scores are converted to T-scores. Lower change from baseline T-scores (<0) represent a better outcome. Baseline and Week 7 (End of Study)
Secondary Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"] An additional secondary endpoint was the percentage of subjects who were "improved" by visit; "improved" was defined as a subject who had a Clinical Global Impression - Improvement (CGI-I) score of 1 = "Very Much Improved" or 2 = "Much Improved". Values range from 0 to 100%. A higher percentage represents a greater number of subjects who were "improved". Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7
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