CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
IR Viloxazine +1 moredrug
Likely dose
IR Viloxazine 50mgfrom 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/NCT01107496
NCT01107496Phase 2Completed
CompareCT.gov

A Phase I/IIa Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Immediate-Release Viloxazine in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Supernus Pharmaceuticals, Inc.·interventional·Posted Apr 21, 2010·Updated Oct 15, 2024

In Brief

A Phase 2 clinical trial evaluating IR Viloxazine and Placebo for Attention-Deficit/Hyperactivity Disorder (ADHD). Completed, enrolled 52 participants across 4 sites.

Detailed Summary

This will be a randomized, double-blind, placebo-controlled, parallel group, safety and tolerability study in adults with ADHD. The target subjects are healthy male or female adults aged 18 to 64 years, inclusive, with a diagnosis of ADHD.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 21, 2010
Enrollment StartJun 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.2 years ago

Interventions

IR Viloxazinedrug

One 50mg immediate-release viloxazine capsule administered orally 3 times a day (150mg total daily dose) for Week 1. Two 50mg immediate-release viloxazine capsules administered orally 3 times a day (300mg total daily dose) for Weeks 2 to 6.

Placebodrug

Placebo capsules administered orally 3 times a day