Trial · NCT03618030
PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT03618030, Phase 3, Completed, Purdue Pharma, Canada; results first posted 2021-07-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT03618030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03618030
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
- NCT number
- NCT03618030
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 288 participants, actual
- Lead sponsor
- Purdue Pharma, Canada
- Conditions
- ADHD
- Interventions
- PRC-063 oral capsules, Placebo oral capsules
- First posted
- 2018-08-07
- Last updated
- 2021-07-26
- Results first posted
- 2021-07-26
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit | Full-day ALC - 13 hours | PERMP-T measures the number of completed and number of attempted math problems completed during a 10 minute test. The scale ranges from 0 to 800, with a higher score indicating a better outcome. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit | Full-day ALC - 13 hours | The full analysis (FA) population was the group of subjects who were randomized and received at least one dose of double-blind study drug, attended the full-day ALC visit evaluation, and had at least one post-dose PERMP-T evaluation during the full-day ALC visit. The primary efficacy endpoint compared all doses of PRC-063 versus Placebo. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit | Double-Blind Active Treatment | 302.9 | Standard Error 3.50 | score on a scale | |
| Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit | Double-Blind Placebo Treatment | 286.6 | Standard Error 3.52 | score on a scale |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PRC-063 25 mg | 15 | |
| Overall Study | STARTED | PRC-063 35 mg | 14 | |
| Overall Study | STARTED | PRC-063 45 mg | 21 | |
| Overall Study | STARTED | PRC-063 55 mg | 39 | |
| Overall Study | STARTED | PRC-063 70 mg | 36 | |
| Overall Study | STARTED | PRC-063 85 mg | 27 | |
| Overall Study | STARTED | PRC-063 100 mg | 18 | |
| Overall Study | STARTED | Placebo Treatment | 118 | |
| Overall Study | COMPLETED | PRC-063 25 mg | 3 | |
| Overall Study | COMPLETED | PRC-063 35 mg | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events99
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Dose-Optimization | 61 | 285 | |
| other | Headache | Nervous system disorders | Double-Blind PRC-063 25 mg | 0 | 3 | |
| other | Headache | Nervous system disorders | Double-Blind PRC-063 35 mg | 0 | 4 | |
| other | Headache | Nervous system disorders | Double-Blind PRC-063 45 mg | 1 | 15 | |
| other | Headache | Nervous system disorders | Double-Blind PRC-063 55 mg | 0 | 31 | |
| other | Headache | Nervous system disorders | Double-Blind PRC-063 70 mg | 1 | 30 | |
| other | Headache | Nervous system disorders | Double-Blind PRC-063 85 mg | 1 | 22 | |
| other | Headache | Nervous system disorders | Double-Blind PRC-063 100 mg | 2 | 16 | |
| other | Headache | Nervous system disorders | Double-Blind Placebo Treatment | 3 | 118 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | Dose-Optimization | 61 | 285 |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose-Optimization | 0 | 285 |
| Total, all-cause mortality | Double-Blind PRC-063 25 mg | 0 | 3 |
| Total, all-cause mortality | Double-Blind PRC-063 35 mg | 0 | 4 |
| Total, all-cause mortality | Double-Blind PRC-063 45 mg | 0 | 15 |
| Total, all-cause mortality | Double-Blind PRC-063 55 mg | 0 | 31 |
| Total, all-cause mortality | Double-Blind PRC-063 70 mg | 0 | 30 |
| Total, all-cause mortality | Double-Blind PRC-063 85 mg | 0 | 22 |
| Total, all-cause mortality | Double-Blind PRC-063 100 mg | 0 | 16 |
| Total, all-cause mortality | Double-Blind Placebo Treatment | 0 | 118 |
| Total, other adverse events | Dose-Optimization | 167 | 285 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34189995 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03618030
GET https://conductscience.org/api/trials/v1/NCT03618030/flow?page=2