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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)
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.
Details
| Lead sponsor | Supernus Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 52 |
| Start date | 2010-06 |
| Completion | 2010-12 |
Conditions
- Attention-Deficit/Hyperactivity Disorder (ADHD)
Interventions
- IR Viloxazine
- Placebo
Primary outcomes
- Incidence of Adverse Events During 6 Weeks of Treatment — Weeks 1-6
The percent of subjects who took at least one dose of immediate-release viloxazine (Safety Population; N) and who reported at least one Adverse Event (n). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and multiplying the product by 100. The higher the percentage, the higher the incidence in the Safety Population
Countries
United States