NCT02736656

Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)

Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 for the Treatment of Pediatric Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Open label extension, long-term multicenter study of safety and efficacy of SPN-812 in pediatric ADHD patients

Detailed description

This is a multicenter open-label extension study assessing long term safety and efficacy of SPN-812 (viloxazine extended-release capsules) in pediatric subjects with ADHD (A) who completed a Phase 2 (812P202: children 6 to 12 years of age) or one of four Phase 3 trials (812P301/812P303: children 6 to 11 years of age; 812P302/812P304: adolescents 12 to 17 years of age) or (B) who completed a Phase 4 trial (812P401: preschool-age children, 4-5 years of age). The study is divided into two phases, Optimization and Maintenance phases. Subjects in Cohort 'A' who completed a Phase 2 or Phase 3 trial followed protocol Schedule 'A' (exposure up to 72 months). Subjects in Cohort 'B' who complete the Phase 4 trial will follow Schedule 'B' (exposure up to 6 months).

Conditions

• Attention-Deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	SPN-812	Cohort 'A': Children 6-11 yrs of age take 100-400mg SPN-812 once daily by mouth and adolescents 12-17 yrs of age take 100-600mg SPN-812 once daily by mouth. Pediatric subjects in Cohort 'A' are given a choice to extend their participation in the study every 6 months for up to 72 months. Cohort 'B': Pre-school-age children 4-5 yrs of age take 100mg SPN-812 once daily by mouth. Pediatric subjects in Cohort 'B' will be treated with 100 mg SPN-812 (100 mg capsule) for up to 6 months.

Timeline

• Start date: 2016-02-02
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2016-04-13
• Last updated: 2025-06-25

Locations

16 sites across 1 country: United States