PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03618030 |
Recruitment Status :
Completed
First Posted : August 7, 2018
Results First Posted : July 26, 2021
Last Update Posted : July 26, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
ADHD | Drug: PRC-063 oral capsules Drug: Placebo oral capsules | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 288 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Adult Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Adults With ADHD |
Actual Study Start Date : | August 21, 2018 |
Actual Primary Completion Date : | July 5, 2019 |
Actual Study Completion Date : | July 5, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Active Treatment
PRC-063 25, 35, 45, 55, 70, 85, or 100 mg
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Drug: PRC-063 oral capsules
Daily dose |
Placebo Comparator: Placebo Treatment
Matched placebo
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Drug: Placebo oral capsules
Daily dose |
- Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males or females 18 to 60 years of age
- Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, or licensed allied healthcare professional
- Subject is willing and able to comply with all the protocol requirements.
Exclusion Criteria:
- Primary and/or comorbid psychiatric diagnosis other than ADHD
- Has a current or recent history of hypertension, symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug;
- Has used any investigational drug within 30 days of the screening visit;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618030
United States, Florida | |
Meridien Research Inc. | |
Bradenton, Florida, United States, 34201 | |
Meridien Research | |
Lakeland, Florida, United States, 33805 | |
Meridien Research Inc. | |
Maitland, Florida, United States, 32751 | |
United States, Massachusetts | |
South Shore Psychiatric Services | |
Hingham, Massachusetts, United States, 02043 | |
United States, Nevada | |
Center for Psychiatry and Behavioral Medicine | |
Las Vegas, Nevada, United States, 89128 | |
United States, North Carolina | |
Center for Psychiatry and Behavioral Medicine | |
Durham, North Carolina, United States, 27705 | |
United States, Pennsylvania | |
Penn State Health Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17004 | |
United States, Texas | |
Bayou City Research | |
Houston, Texas, United States, 77007 |
Study Director: | Sailaja Bhaskar, PhD | Purdue Pharma, Canada |
Documents provided by Purdue Pharma, Canada:
Responsible Party: | Purdue Pharma, Canada |
ClinicalTrials.gov Identifier: | NCT03618030 |
Other Study ID Numbers: |
063-020 |
First Posted: | August 7, 2018 Key Record Dates |
Results First Posted: | July 26, 2021 |
Last Update Posted: | July 26, 2021 |
Last Verified: | July 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |