This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120 subjects will be randomized across approximately 30 US centers to one of four treatment groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
administered orally
administered orally
Unnamed facility
Dothan, Alabama, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Santa Ana, California, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Bradenton, Florida, United States
Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Hialeah, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Maitland, Florida, United States
Unnamed facility
North Miami, Florida, United States
...and 17 more locations
Reduction in aggressive behavior as assessed by R-MOAS score
Time frame: Change from baseline to Visit 10
Safety of SPN-810 Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
Time frame: Visit 2 to End of Study
Change in CGI-S
Time frame: Baseline to Visit 5
CGI-I score at each post-baseline Visit
Time frame: Baseline to Visit 5
Change in SNAP-IV ADHD scores
Time frame: Baseline to Visit 5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.