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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryPost-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom VisitFull-day ALC - 13 hoursPERMP-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.

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPost-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom VisitFull-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 scaleLEAST_SQUARES_MEAN

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom VisitDouble-Blind Active Treatment302.9Standard Error 3.50score on a scale
Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom VisitDouble-Blind Placebo Treatment286.6Standard Error 3.52score on a scale

Participant flow24

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPRC-063 25 mg15
Overall StudySTARTEDPRC-063 35 mg14
Overall StudySTARTEDPRC-063 45 mg21
Overall StudySTARTEDPRC-063 55 mg39
Overall StudySTARTEDPRC-063 70 mg36
Overall StudySTARTEDPRC-063 85 mg27
Overall StudySTARTEDPRC-063 100 mg18
Overall StudySTARTEDPlacebo Treatment118
Overall StudyCOMPLETEDPRC-063 25 mg3
Overall StudyCOMPLETEDPRC-063 35 mg3

Adverse events99

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherHeadacheNervous system disordersDose-Optimization61285
otherHeadacheNervous system disordersDouble-Blind PRC-063 25 mg03
otherHeadacheNervous system disordersDouble-Blind PRC-063 35 mg04
otherHeadacheNervous system disordersDouble-Blind PRC-063 45 mg115
otherHeadacheNervous system disordersDouble-Blind PRC-063 55 mg031
otherHeadacheNervous system disordersDouble-Blind PRC-063 70 mg130
otherHeadacheNervous system disordersDouble-Blind PRC-063 85 mg122
otherHeadacheNervous system disordersDouble-Blind PRC-063 100 mg216
otherHeadacheNervous system disordersDouble-Blind Placebo Treatment3118
otherDecreased AppetiteMetabolism and nutrition disordersDose-Optimization61285

Adverse event totals27

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityDose-Optimization0285
Total, all-cause mortalityDouble-Blind PRC-063 25 mg03
Total, all-cause mortalityDouble-Blind PRC-063 35 mg04
Total, all-cause mortalityDouble-Blind PRC-063 45 mg015
Total, all-cause mortalityDouble-Blind PRC-063 55 mg031
Total, all-cause mortalityDouble-Blind PRC-063 70 mg030
Total, all-cause mortalityDouble-Blind PRC-063 85 mg022
Total, all-cause mortalityDouble-Blind PRC-063 100 mg016
Total, all-cause mortalityDouble-Blind Placebo Treatment0118
Total, other adverse eventsDose-Optimization167285

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
34189995DERIVED

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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