NCT03247556

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) 400 and 600 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of high doses of SPN-812 in adolescents (12-17 years old) with ADHD

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group study to assess the efficacy and safety of SPN-812 as a monotherapy for the treatment of adolescents 12-17 years old with ADHD.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	Placebo	Placebo was administered once daily
DRUG	400mg SPN-812	400mg SPN-812 was administered once daily and compared to Placebo
DRUG	600mg SPN-812	600mg SPN-812 was administered once daily and compared to Placebo

Timeline

• Start date: 2017-11-20
• Primary completion: 2019-02-14
• Completion: 2019-02-14
• First posted: 2017-08-11
• Last updated: 2021-07-02
• Results posted: 2021-07-02

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study