At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 156 enrolled
Drug / intervention
PRC-063 oral capsules +1 moredrug
Likely dose
Not stated in 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 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
In Brief
A Phase 3 clinical trial evaluating PRC-063 oral capsules and Placebo oral capsules for ADHD. Completed, enrolled 156 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartMay 2017
First PostedJun 2017
Primary CompletionAug 2017
Study CompletionDec 2017
TodayJul 2026
First PostedJun 1, 2017
Enrollment StartMay 1, 2017
Primary CompletionAug 19, 2017
Study CompletionDec 19, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.1 years ago
Interventions
PRC-063 oral capsulesdrug
Daily dose
Placebo oral capsulesdrug
Daily dose