A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

Phase 2

Completed

• Conditions: Impulsive Aggression Comorbid With ADHD
• Interventions: Drug: Placebo; Drug: SPN-810

• Registration Number: NCT01364662
• Lead Sponsor: Supernus Pharmaceuticals, Inc.

Brief Summary

This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120 subjects will be randomized across approximately 30 US centers to one of four treatment groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-25
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Disposition First Submitted: 2013-05-22
• Disposition First Submitted QC: 2013-05-22
• Disposition First Posted: 2013-06-05
• Status Verified: 2015-11
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

1. Healthy pediatric male or female subjects, age 6 to 12 years.
2. Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
3. R-MOAS score >=24 at screening and R-MOAS score >=20 for randomization
4. IQ greater than 71.
5. Weight of >=20kg
6. current treatment with psychostimulant (1 month prior to screening)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2	SPN-810	-
3	SPN-810	-
4	SPN-810	-

Primary Outcome Measures

Name	Time	Method
Reduction in aggressive behavior as assessed by R-MOAS score	Change from baseline to Visit 10

Secondary Outcome Measures

Name	Time	Method
Safety of SPN-810 Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs	Visit 2 to End of Study	Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
Change in CGI-S	Baseline to Visit 5
CGI-I score at each post-baseline Visit	Baseline to Visit 5
Change in SNAP-IV ADHD scores	Baseline to Visit 5