Trials / Completed
CompletedNCT03172481
PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Children (6-12 Years of Age) With ADHD
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 156 (actual)
- Sponsor
- Purdue Pharma, Canada · Industry
- Sex
- All
- Age
- 6 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric subjects between 6 to 12 years of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRC-063 oral capsules | Daily dose |
| DRUG | Placebo oral capsules | Daily dose |
Timeline
- Start date
- 2017-05-01
- Primary completion
- 2017-08-19
- Completion
- 2017-12-19
- First posted
- 2017-06-01
- Last updated
- 2019-11-05
- Results posted
- 2019-06-04
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03172481. Inclusion in this directory is not an endorsement.