Last updated on April 2019

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


Brief description of study

The purpose of this study is to demonstrate the efficacy, safety and tolerability of SPN-810 in the treatment of impulsive aggression in subjects with Attention Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 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.

Clinical Study Identifier: NCT02618408

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