NCT02633527

Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD

Evaluation of the Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD - A Double-Blind, Placebo-Controlled, Dose-Ranging Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.

Detailed description

This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV).

Conditions

• Attention-Deficit/Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	Placebo	Placebo was administered once daily
DRUG	100mg SPN-812	100mg SPN-812 was administered once daily and compared to placebo
DRUG	200mg SPN-812	200mg SPN-812 was administered once daily and compared to placebo
DRUG	300mg SPN-812	300mg SPN-812 was administered once daily and compared to placebo
DRUG	400mg SPN-812	400mg SPN-812 was administered once daily and compared to placebo

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-07-25
• Completion: 2016-07-25
• First posted: 2015-12-17
• Last updated: 2021-10-27
• Results posted: 2021-10-27

Locations

1 site across 1 country: United States