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NCT03172481 · ClinicalTrials.gov registry record · Phase 3
PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD
A Phase 3 study of ADHD, sponsored by Purdue Pharma, Canada.
- Completed
- Registry status
- Phase 3
- Development phase
- 156
- Enrollment target
- 6
- Study locations
NCT03172481: Completed Phase 3 study of ADHD, sponsored by Purdue Pharma, Canada.
NCT03172481 is a Phase 3 study of ADHD that has completed, run by Purdue Pharma, Canada. The registered enrollment target is 156 participants, below the 188-participant average among 75 other ADHD trials with a reported enrollment target (17% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03172481, a Phase 3 study of ADHD, has completed, sponsored by Purdue Pharma, Canada.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 156 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
The SKAMP rating scale is a validated tool that assesses behavioral symptoms of ADHD in a classroom setting. The SKAMP-C comprises 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13), and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0 = none, 6 = maximal impairment), for a total possible combined score of 0 to 78 (lower score indicated fewer ADHD s
Conditions Studied
Interventions
- DRUG Placebo oral capsules
- DRUG PRC-063 oral capsules
Study Locations (6)
Florida
- Meridien Research Inc. - Bradenton
- Meridien Research Inc. - Maitland
- Qps Mra Llc - Miami
California
- AVIDA Inc. - Newport Beach
Nevada
- Center for Psychiatry and Behavioral Medicine - Las Vegas
Texas
- Bayou City Research - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2017-12-19 |
| Phase | Phase 3 |
What the finished NCT03172481 record still lists
NCT03172481 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 188-participant average among 75 other ADHD trials with a reported enrollment target (17% lower).
The record links to 1 condition, with ADHD appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral capsules is the first listed.
NCT03172481 lists 6 locations in 4 states (Florida, California, Nevada).
Frequently Asked Questions
What is clinical trial NCT03172481 about?
NCT03172481 is a clinical study titled "PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD". 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.
What is the current status of trial NCT03172481?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2017-05-01. Estimated completion is 2017-12-19.
What conditions does trial NCT03172481 study?
This clinical trial studies the following conditions: ADHD.
What interventions are being tested in trial NCT03172481?
The interventions under investigation include: Placebo oral capsules (DRUG), PRC-063 oral capsules (DRUG).
Who is sponsoring clinical trial NCT03172481?
This trial is sponsored by Purdue Pharma, Canada, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03172481 being conducted?
This trial has 6 study locations across California, Florida, Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for ADHD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03172481's enrollment target sits among peer trials
156 24th of 75 higher than 52 of 75 other ADHD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ADHD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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