PHARM - Childhood Impulsive Aggression and Molindone Extended Release Open Label Study
Project Description:
The present study is designed to collect long-term safety data for the use of SPN-810 in the treatment of IA in subjects aged 6 to 12 years comorbid with ADHD. SPN-810 was used in Phase 2 and Phase 3 studies for the treatment of IA in children with ADHD who experienced IA behaviors despite monotherapy treatment with an FDA-approved ADHD medication.
The patient population will be eligible to enter in this study after the compleion of the double-blind studies 810P301 or 810P302. At Visit 6 of 810P301 and 810P302 studies, subjects are invited to convert from their randomized dose in a blinded fashion to a dose of 18 mg/day (9 mg/day BID), the initial total daily dose for this OLE study.
Study 810P3404 is a multicenter, open-label, extension study aimed to assess safety of SPN-810 in the treatment of IA in patients aged 6-12 years with ADHD in conjunction with standard ADHD treatment. The study has three phases: Optimization, Maintenance, and Taper.
Keyword(s):
ADHD, Aggression, Molindone, ADD, Medication
Core Function(s):
Performing Research or Evaluation
Area of Emphasis
Child Care-Related Activities, Health-Related Activities, Quality of Life
Target Audience:
Professionals and Para-Professionals, Family Members/Caregivers, Children/Adolescents with Disabilities/SHCN, General Public
Unserved or Under-served Populations:
Racial or Ethnic Minorities, Disadvantaged Circumstances, Geographic Areas, Rural/Remote, Urban, Specific Groups
Primary Target Audience Geographic Descriptor:
State, Regional, National
COVID-19 Related Data:
N/A
