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PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT03618030
Recruitment Status : Completed
First Posted : August 7, 2018
Results First Posted : July 26, 2021
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma, Canada

Study Description
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Brief 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 adults

Condition or disease Intervention/treatment Phase
ADHD Drug: PRC-063 oral capsules Drug: Placebo oral capsules Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Treatment
PRC-063 25, 35, 45, 55, 70, 85, or 100 mg
 Drug: PRC-063 oral capsules
Daily dose
Placebo Comparator: Placebo Treatment
Matched placebo
 Drug: Placebo oral capsules
Daily dose


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females 18 to 60 years of age
  2. Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, or licensed allied healthcare professional
  3. Subject is willing and able to comply with all the protocol requirements.

Exclusion Criteria:

  1. Primary and/or comorbid psychiatric diagnosis other than ADHD
  2. 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;
  3. Has used any investigational drug within 30 days of the screening visit;
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Purdue Pharma, Canada
Investigators
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Study Director: Sailaja Bhaskar, PhD Purdue Pharma, Canada
  Study Documents (Full-Text)

Documents provided by Purdue Pharma, Canada:
Study Protocol and Statistical Analysis Plan  [PDF] April 24, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No