Trial · NCT02139124
The Efficacy and Safety of PRC-063 in Adult ADHD Patients
NCT02139124, Phase 3, Completed, Rhodes Pharmaceuticals, L.P.; results first posted 2019-05-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Efficacy and Safety of PRC-063 in Adult ADHD Patients. Trials, record NCT02139124. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02139124
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy and Safety of PRC-063 in Adult ADHD Patients
- NCT number
- NCT02139124
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 375 participants, actual
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.
- Conditions
- ADHD
- Interventions
- Placebo, PRC-063 25 mg, PRC-063 45 mg, PRC-063 70 mg, PRC-063 100 mg
- First posted
- 2014-05-15
- Last updated
- 2019-05-07
- Results first posted
- 2019-05-07
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score | 4 weeks | Participants were monitored for 4 weeks on treatment (final 2 weeks on stable dose). Clinicians rated subject behavior on the ADHD-5-Rating Scale each week. Primary outcome was based on the final week of treatment. The ADHD-5-RS is an 18-item questionnaire that measures the frequency of ADHD symptoms based on DSM-5 criteria. For each item, clinicians rate how often the behavior is displayed on a scale of 0 (Never or Rarely) to 3 (Very Often). Scores can range from 0 to 54, with lower scores indicating a lower frequency of ADHD symptoms. |
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 | Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score | 4 weeks | The Full Analysis population consists of all randomized subjects who receive any amount of study medication and who have any ADHD-5-Rating Scale assessments. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score | PRC-063 25 mg | 24.2 | Standard Deviation 11.88 | units on a scale | |
| Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score | PRC-063 45 mg | 19.9 | Standard Deviation 12.45 | units on a scale | |
| Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score | PRC-063 70 mg | 24.0 | Standard Deviation 11.25 | units on a scale | |
| Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score | PRC-063 100 mg | 18.7 | Standard Deviation 11.48 | units on a scale | |
| Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score | 0 mg/Day | 26.1 | Standard Deviation 11.99 | units on a scale |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 78 | |
| Overall Study | STARTED | PRC-063 25 mg | 77 | |
| Overall Study | STARTED | PRC-063 45 mg | 73 | |
| Overall Study | STARTED | PRC-063 70 mg | 73 | |
| Overall Study | STARTED | PRC-063 100 mg | 74 | |
| Overall Study | COMPLETED | Placebo | 69 | |
| Overall Study | COMPLETED | PRC-063 25 mg | 73 | |
| Overall Study | COMPLETED | PRC-063 45 mg | 69 | |
| Overall Study | COMPLETED | PRC-063 70 mg | 61 | |
| Overall Study | COMPLETED | PRC-063 100 mg | 61 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events505
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 | conduction disorder | Cardiac disorders | Placebo | 0 | 78 | 0 |
| other | conduction disorder | Cardiac disorders | PRC-063 25 mg | 1 | 77 | 1 |
| other | conduction disorder | Cardiac disorders | PRC-063 45 mg | 0 | 73 | 0 |
| other | conduction disorder | Cardiac disorders | PRC-063 70 mg | 0 | 73 | 0 |
| other | conduction disorder | Cardiac disorders | PRC-063 100 mg | 0 | 74 | 0 |
| other | palpitations | Cardiac disorders | Placebo | 1 | 78 | 1 |
| other | palpitations | Cardiac disorders | PRC-063 25 mg | 0 | 77 | 0 |
| other | palpitations | Cardiac disorders | PRC-063 45 mg | 0 | 73 | 0 |
| other | palpitations | Cardiac disorders | PRC-063 70 mg | 3 | 73 | 4 |
| other | palpitations | Cardiac disorders | PRC-063 100 mg | 1 | 74 | 1 |
1 to 10 of 505Source ClinicalTrials.gov
See all 505 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | PRC-063 25 mg | ||
| Total, all-cause mortality | PRC-063 45 mg | ||
| Total, all-cause mortality | PRC-063 70 mg | ||
| Total, all-cause mortality | PRC-063 100 mg | ||
| Total, other adverse events | Placebo | 25 | 78 |
| Total, other adverse events | PRC-063 25 mg | 30 | 77 |
| Total, other adverse events | PRC-063 45 mg | 36 | 73 |
| Total, other adverse events | PRC-063 70 mg | 45 | 73 |
| Total, other adverse events | PRC-063 100 mg | 47 | 74 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT02139124
GET https://conductscience.org/api/trials/v1/NCT02139124/events?page=2