Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)
Status:
Completed
Trial end date:
2020-04-01
Target enrollment:
Participant gender:
Summary
Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid
with ADHD and have participated in the 810P301 or 810P302 study are invited to participate in
this study. This is a Phase 3 open label extension (OLE) study with the objective of
collecting long-term safety data on the use of SPN-810 in treating impulsive aggression in
pediatric subjects with ADHD, when taken in conjunction with standard ADHD treatment. After
confirmation of eligibility, all subjects will be treated with SPN-810.Subjects will be given
a choice to extend participation in this study every 6 months for up to 36 months.