Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
Status:
Completed
Trial end date:
2019-11-01
Target enrollment:
Participant gender:
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 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.