NCT01364662

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)

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Impulsive Aggression Comorbid With ADHD

Interventions

Type	Name	Description
DRUG	SPN-810	administered orally
DRUG	Placebo	administered orally

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-06-02
• Last updated: 2021-02-11

Locations

27 sites across 1 country: United States