Summary
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Molindone Hydrochloride Extended-Release Tablets for the Treatment of Impulsive Aggression in Pediatric Patients with Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction with Standard ADHD Treatment
Total # of Subjects Needed:
Approximately 378 subjects aged 6-12 years (inclusive) will be screened.
Study Details
This research study is being done by a company called the “sponsor”, which conducts research studies. The name of the sponsor is Supernus Pharmaceuticals. The drug being studied is called SPN-810. SPN-810 is an “investigational drug”. The purpose of this study is to find out how well SPN-810 works in reducing impulsive aggressive behaviors in patients with ADHD.
After screening it will be decided whether the child is suitable to be part of this study and will receive either SPN-810 or placebo (sugar pill with no active drug), which looks like the study drug. Both the placebo and SPN-810 are to be taken orally twice a day according to the instructions which you will receive at the study doctor’s office.
It will be decided randomly (like drawing straws) if the child will receive SPN-810 or placebo. The child will receive treatment at increasing doses for 2 weeks until the final dose is decided. The child will continue to get that final dose for 3 weeks. At the end of this time, the child can choose to continue to receive study drug even if he/she received placebo in the main study. If the child does not want to continue, he/she will be asked to go to the study clinic to complete some procedures, which are done for the child’s safety.
Information About SPN-810
SPN-810 was approved in the US as MOBAN® for the treatment of schizophrenia in adults and adolescents. Studies done before approval showed that treatment with SPN-810 three times daily was safe and well tolerated. Improvements in behavior were seen in children with ADHD.
Therefore, SPN-810 is being tested in this large (Phase 3) study to see how safe it is and how well it works when given with other medicines the child may be on.
Apply for study
If you would like to learn more about the different study opportunities you may call 1-800-530-0998 or for local callers please call 801-356-5555. To apply for this study fill out the online application HERE.