At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 360 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
PRC-063 25 mgfrom 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.
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adolescent ADHD Patients
In Brief
A Phase 3 clinical trial evaluating Placebo, PRC-063 25 mg, and 3 other interventions for ADHD. Completed, enrolled 360 participants across 43 sites in 2 countries.
Detailed Summary
The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adolescents with ADHD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesCanada, United States
CollaboratorsPurdue Pharma LP
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedMay 2014
Primary CompletionMar 2015
Study CompletionMay 2015
TodayJul 2026
First PostedMay 15, 2014
Enrollment StartApr 1, 2014
Primary CompletionMar 1, 2015
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.1 years ago
Interventions
Placebodrug
Oral placebo capsule
PRC-063 25 mgdrug
Oral 25 mg capsule - active
PRC-063 45 mgdrug
Oral 45 mg capsule - active
PRC-063 70 mgdrug
Oral 70 mg capsule - active
PRC-063 85 mgdrug
Oral 85 mg capsule - active