Purpose

The purpose of this study is 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.

Condition

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Otherwise, healthy non-smoking, male and females adolescents (12-17 years of age at the time of screening) with a primary diagnosis of ADHD and currently taking an optimized FDA-approved ADHD medication.
  • IA will be confirmed at screening using R-MOAS scale and Vitiello Aggression Questionnaire.

Exclusion Criteria

  • History or current diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia and other psychotic disorders, personality disorder, Tourette's syndrome or dissociative disorder, autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or intermittent explosive disorder.
  • Currently meeting DSM-5 criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder or intermittent explosive disorder.
  • Known or suspected intelligence quotient (IQ) <70, active suicidal plan/intent or active suicidal thought, criminal arrest, alcohol or drug use or pregnancy.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double-blind, randomized, parallel group, two-arm, placebo-controlled study with flexible dosing
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Flexible dose of SPN-810
Subjects will be treated with flexible dose of SPN-810
  • Drug: SPN-810
    Flexible dose
Placebo Comparator
Placebo
Subjects will be treated with Placebo
  • Drug: Placebo
    Placebo

Recruiting Locations

Children's National and nearby locations

Children's National Medical Center/Children's Research Institute
Washington, District of Columbia 20310
Contact:
Robb Adelaide, MD
202-476-3042
arobb@childrensnational.org

More Details

NCT ID
NCT03597503
Status
Recruiting
Sponsor
Supernus Pharmaceuticals, Inc.

Study Contact

Ronald Marcus, MD
301-838-2569
rmarcus@supernus.com

Detailed Description

This study is an addition to the ongoing 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 will be administered in patients diagnosed with ADHD and associated feature of IA, who are currently being treated with an FDA-approved standard ADHD treatment and with persistent IA behaviors. The frequency of impulsive aggressive behaviors will be assessed as a primary outcome.

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Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.