Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)

Last updated: March 15, 2024
Sponsor: Supernus Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Tourette's Syndrome

Learning Disorders

Treatment

SPN-810 (18 mg)

SPN-810 (36 mg)

Placebo

Clinical Study ID

NCT02618434
810P302
  • Ages 6-12
  • All Genders

Study Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 297 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Otherwise healthy male or female subjects, age 6 to 12 years at the time of screeningwith a primary diagnosis of ADHD and currently receiving monotherapy treatment with anoptimized FDA-approved ADHD medication.
  • Impulsive aggression will be confirmed at screening using R-MOAS and VitielloAggression Scale.

Exclusion

Exclusion Criteria:

  • Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolardisorder, schizophrenia or a related disorder, personality disorder, Tourette'sdisorder, or psychosis not otherwise specified.
  • Currently meeting DSM criteria for autism spectrum disorder, pervasive developmentaldisorder, obsessive-compulsive disorder, post-traumatic stress disorder, or any otheranxiety disorder as the primary diagnosis.
  • Known or suspected intelligence quotient (IQ) < 70, suicidality, pregnancy, orsubstance or alcohol abuse.

Study Design

Total Participants: 297
Treatment Group(s): 3
Primary Treatment: SPN-810 (18 mg)
Phase: 3
Study Start date:
February 16, 2016
Estimated Completion Date:
February 14, 2020

Study Description

This study is a randomized, placebo-controlled, double-blind, multicenter, parallel group, fixed dose study to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of IA in subjects aged 6 to 12 years with ADHD in conjunction with standard ADHD treatment.

Connect with a study center

  • Metropolitan Neuro Behavioral Institute

    Chandler, Arizona 85226
    United States

    Site Not Available

  • Woodland International Research Group

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Sun Valley Research Center

    Imperial, California 92251
    United States

    Site Not Available

  • Alliance for Wellness dba Alliance for Research

    Long Beach, California 90807
    United States

    Site Not Available

  • ASCLEPES Research Center

    Panorama City, California 91402
    United States

    Site Not Available

  • MCB Clinical Research Centers, LLC

    Colorado Springs, Colorado 80910
    United States

    Site Not Available

  • Children's National Medical Center/Children's Research Institute

    Washington, District of Columbia 20310
    United States

    Site Not Available

  • Children's National Medical Center/Children's Research Institute

    Washington, D.C., District of Columbia 20310
    United States

    Site Not Available

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Indago Research & Health Center, Inc.

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Innovative Clinical Research, Inc

    Lauderhill, Florida 33319
    United States

    Site Not Available

  • Laszlo J. Mate, M.D., P.A.

    North Palm Beach, Florida 71103
    United States

    Site Not Available

  • APG Research, LLC

    Orlando, Florida 32803
    United States

    Site Not Available

  • Miami Research Associates

    South Miami, Florida 33143
    United States

    Site Not Available

  • University of South Florida- Dept. of Psychiatry and Neurosciences

    Tampa, Florida 33613
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • iResearch Atlanta

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Advanced Clinical Research

    Meridian, Idaho 83642
    United States

    Site Not Available

  • AMR Conventions Research

    Naperville, Illinois 60563
    United States

    Site Not Available

  • Pedia Research

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Pedia Research

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Louisiana State University Health Sciences Center

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • St. Charles Psychiatric Associates Midwest Research Center

    Saint Charles, Missouri 63304
    United States

    Site Not Available

  • St. Charles Psychiatric Associates Midwest Research Center

    St. Charles, Missouri 63304
    United States

    Site Not Available

  • Alivation Research, LLC

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Quality Clinical Research

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Hassmann Research Institute

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • University of Cincinnati Department of Psychiatry and Behavioral Neuroscience

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • BioBehavioral Research of Austin P.C.

    Austin, Texas 78759
    United States

    Site Not Available

  • InSite Clinical Research

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Houston Clinical Trials

    Houston, Texas
    United States

    Site Not Available

  • Ericksen Research & Development

    Clinton, Utah 84015
    United States

    Site Not Available

  • Pacific Institute of Medical Sciences

    Bothell, Washington 98011
    United States

    Site Not Available

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