Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD

Phase 2

Completed

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Interventions: Drug: Placebo
Drug: 100mg SPN-812
Drug: 200mg SPN-812
Drug: 300mg SPN-812
Drug: 400mg SPN-812

Registration Number: NCT02633527

Lead Sponsor: Supernus Pharmaceuticals, Inc.

Brief Summary: This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.

Detailed Description: This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 222

Inclusion Criteria

Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.
CGI-S score of at least 4
Weight of at least 20 kg.
Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.

Exclusion Criteria

Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
Significant systemic disease.
Evidence of suicidality within the six months before Screening or at Screening.
BMI greater than 95th percentile for the appropriate age and gender.
Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).
Substance or alcohol use during the last three months.
Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, qd, oral capsule
100mg SPN-812	100mg SPN-812	100mg SPN-812, qd, oral capsule
200mg SPN-812	200mg SPN-812	200mg SPN-812, qd, oral capsule
300mg SPN-812	300mg SPN-812	300mg SPN-812, qd, oral capsule
400mg SPN-812	400mg SPN-812	400mg SPN-812, qd, oral capsule

Primary Outcome Measures

Name	Time	Method
The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV)	Baseline to Week 8 (End of Study)	The Primary Endpoint was the change from baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) Total score at Week 8 (End of Study). The ADHD-RS-IV 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, 4th Edition (DSM-IV) 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.

Secondary Outcome Measures

Name	Time	Method
Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Scale	Week 8 (End of Study)	The first additional secondary endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 8 (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", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". Successful therapy is indicated by a lower score (\<4) in subsequent testing.
Effect of SPN-812 on the Clinical Global Impression - Severity (CGI-S) Scale	Baseline to Week 8 (End of Study)	The second additional secondary endpoint was the change from baseline in the Clinical Global Impression-Severity (CGI-S) Scale score at Week 8 (End of Study). The CGI-S scale is a single item clinician/investigator rating of the clinician's assessment of the severity of the ADHD symptoms in relation to the clinician's total experience with patients with ADHD. The CGI-S was rated on a 7-point Likert scale, where 1 = Normal, not at all ill, 2 = Borderline Ill, 3 = Mildly Ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, and 7 = Extremely Ill. Successful therapy is indicated by a lower CGI-S score in subsequent testing. A lower change from baseline score (\<0) represents a better outcome.