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)

Impulsive Aggression Comorbid With ADHD Clinical Trial

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 Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Aggression
• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis
• Impulsive Aggression Comorbid With ADHD
• Impulsive Behavior

• NCT number: NCT01364662
• Study type: Interventional
• Source: Supernus Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: June 2011
• Completion date: October 2012