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Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:
Assessment of Efficacy and Safety of SPN-810 for the Treatment of Impulsive Aggression (IA) in Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment

Clinical Trial Summary

The purpose of this study was to evaluate the effect of SPN-810 for the treatment of impulsive aggression (IA) in adolescents diagnosed with ADHD when taken in conjunction with standard ADHD treatment.

Clinical Trial Description

This study was an addition to the pediatric studies (CHIME 1 and CHIME 2) to assess the efficacy and safety of SPN-810 in the improvement of impulsive aggression (IA) behaviors in adolescents with ADHD. SPN-810 was administered in patients diagnosed with ADHD and associated features of IA, who were currently treated with an FDA-approved standard ADHD treatment and displayed persistent IA behaviors. The frequency of impulsive aggressive behaviors was assessed as a primary outcome. . ;

Study Design

Related Conditions & MeSH terms

  • Aggression
  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis
Clinical Trial Details
NCT number NCT03597503
Study type Interventional
Source Supernus Pharmaceuticals, Inc.
Contact
Status Terminated
Phase Phase 3
Start date July 31, 2018
Completion date January 22, 2020
View Details
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