CompletedPhase 3

Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)

United States333 participantsStarted 2016-01-25

Plain-language summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of Impulsive Aggression (IA) in subjects with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 426 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.

Who can participate

Age range6 Years – 12 Years

SexALL

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Inclusion criteria

✓. Healthy male or female subjects, age 6 to 12 years at the time of screening.
✓. Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders- 5 (DSM-5 confirmed by the Schedule for Affective Disorders and Schizophrenia for School-aged Children - Present and Lifetime Version 2013 (K-SADS-PL 2013).
✓. Retrospective Modified Overt Aggression Scale (R-MOAS) score of ≥24 at screening.
✓. CGI-S score of at least moderately ill at both Screening and Randomization.
✓. Vitiello Aggression Scale score from -2 to -5 at screening.
✓. Free of antipsychotic medication for at least two weeks prior to Visit 2.
✓. Monotherapy treatment with FDA-approved optimized ADHD medication (psychostimulant or non-stimulant) at an FDA-approved dose for at least one month prior to screening, and willing to maintain that dose throughout the Baseline and Treatment period.
✓. α 2- adrenergic agonists (e.g., clonidine and guanfacine) used for any other reason except for monotherapy treatment for ADHD (e.g., aggression or insomnia) must be discontinued at least two weeks prior to Visit 2.

Exclusion criteria

What they're measuring

Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary

Timeframe: Daily measure from Visit 2 (Week-2) to Visit 6 (Week 5) for a total of 7 weeks

Trial details

NCT IDNCT02618408

SponsorSupernus Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-04

Results submitted2020-11-02

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder (ADHD) trials