NCT04016779

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Flexible-Dose Study of the Efficacy and Safety of SPN-812 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of SPN-812 (Viloxazine extended-release capsules; 200-600 mg) in adults 18-65 years of age with Attention-Deficit/Hyperactivity Disorder (ADHD).

Detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, 2-arm, parallel-group, flexible dose trial assessing the efficacy and safety of SPN-812 (Viloxazine extended-release capsules; 200-600 mg) as monotherapy for the treatment of adults 18-65 years old with Attention-Deficit/Hyperactivity Disorder (ADHD).

Conditions

• Attention-Deficit/Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	Placebo	Placebo will be administered once daily
DRUG	SPN-812	SPN-812 will be administered once daily and compared to Placebo

Timeline

• Start date: 2019-11-20
• Primary completion: 2020-10-10
• Completion: 2020-10-10
• First posted: 2019-07-11
• Last updated: 2022-07-12
• Results posted: 2022-07-12

Locations

37 sites across 1 country: United States

Regulatory

• FDA-regulated drug study