Clinical Trial: 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)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression

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 Summary:
Sponsor: Supernus Pharmaceuticals, Inc.

Current Primary Outcome: Reduction in aggressive behavior as assessed by R-MOAS score [ Time Frame: after approximately 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety [ Time Frame: after approximately 6 weeks ]

Safety as assessed by safety scales, AEs, clinical labs, vitals, PEs, ECGs, etc


Original Secondary Outcome: Same as current

Information By: Supernus Pharmaceuticals, Inc.

Dates:
Date Received: May 25, 2011
Date Started: June 2011
Date Completion:
Last Updated: November 16, 2015
Last Verified: November 2015