NCT01416064

Open-Label, Extension Study to 810P202

Open-Label Extension Study to Evaluate the Safety of Molindone Hydrochloride Extended-Release Tablets as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Open-label, extension study for subjects that completed 810P202 to examine long term safety and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).

Conditions

• Impulsive Aggression Comorbid With ADHD in Children

Interventions

Type	Name	Description
DRUG	Molindone	The populations will be comprised of male and female pediatric subjects from the 810P202 study. Subject will be converted to a total daily dose of 18 or 36mg of molindone (depending on weight), following enrollment into 810P203. The dosage level may be adjusted at the investigators discretion.

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2011-08-12
• Last updated: 2017-05-02

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study