CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 222 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
100mg SPN-812from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02633527
NCT02633527Phase 2Completed
CompareCT.gov

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

Supernus Pharmaceuticals, Inc.·interventional·Posted Dec 17, 2015·Updated Oct 27, 2021

In Brief

A Phase 2 clinical trial evaluating Placebo, 100mg SPN-812, and 3 other interventions for Attention-Deficit/Hyperactivity Disorder (ADHD). Completed, enrolled 222 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention-Deficit/Hyperactivity Disorder (ADHD)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 17, 2015
Enrollment StartFeb 1, 2016
Primary CompletionJul 25, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.5 years ago

Interventions

Placebodrug

Placebo was administered once daily

100mg SPN-812drug

100mg SPN-812 was administered once daily and compared to placebo

200mg SPN-812drug

200mg SPN-812 was administered once daily and compared to placebo

300mg SPN-812drug

300mg SPN-812 was administered once daily and compared to placebo

400mg SPN-812drug

400mg SPN-812 was administered once daily and compared to placebo