Trials / Completed
CompletedNCT03247517
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Adolescents With ADHD
Evaluation of SPN 812 (Viloxazine Extended-release Capsule) 200 and 400 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 310 (actual)
- Sponsor
- Supernus Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of low doses of SPN-812 in adolescents 12-17 years of age.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group study, to assess the efficacy and safety of SPN-812 as monotherapy for the treatment of adolescents 12-17 years old with ADHD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo was administered once daily |
| DRUG | 200mg SPN-812 | 200mg 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
- 2017-11-02
- Primary completion
- 2018-10-17
- Completion
- 2018-10-17
- First posted
- 2017-08-11
- Last updated
- 2021-06-18
- Results posted
- 2021-06-18
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03247517. Inclusion in this directory is not an endorsement.