NCT02691182

Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)

Open-Label Extension Study to Evaluate the Long-Term Safety of Molindone Hydrochloride Extended-Release Tablets for the Treatment of Impulsive Aggression in Pediatric and Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 491 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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 were invited to participate in this study. This was a Phase 3 open-label extension (OLE) study to collect 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 were treated with SPN-810. Subjects were given a choice to extend participation in this study every 6 months for up to 36 months.

Detailed description

Study 810P304 is a multicenter, open-label, extension study aimed to assess safety of SPN-810 in the treatment of IA in patients aged 6-17 years with ADHD in conjunction with standard ADHD treatment. The study has three phases: Optimization, Maintenance, and Taper. All subjects who complete the randomized, double-blind portion of study 810P301, 810P302, 810P503 or 810P204 will have the option to participate in the OLE study in which all subjects will receive active Study Medication (SM) treatment. Subjects who choose to participate in the OLE will receive blinded conversion medication kits at Visit 6 of the previous SPN-810 double-blind randomization study (810P301, 810P302) or at Visit 4 for subjects completing the 810P204 study. Subjects, who have completed the 810P503 study and, chose to participate in this study, will receive the blinded conversion card at Visit 7.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	SPN-810

Timeline

• Start date: 2016-04-01
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2016-02-25
• Last updated: 2024-05-16
• Results posted: 2024-05-16

Locations

1 site across 1 country: United States