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Trial record 1 of 1 for:    NCT03618030
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PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

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
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma, Canada

Tracking Information
First Submitted Date  ICMJE August 1, 2018
First Posted Date  ICMJE August 7, 2018
Results First Submitted Date  ICMJE October 29, 2020
Results First Posted Date  ICMJE July 26, 2021
Last Update Posted Date July 26, 2021
Actual Study Start Date  ICMJE August 21, 2018
Actual Primary Completion Date July 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
Change in PERMP-T scores [ Time Frame: Across entire classroom day [Day 56] ]
Mean Change in PERMP-T scores compared to placebo
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE ADHD
Intervention  ICMJE
  • Drug: PRC-063 oral capsules
    Daily dose
  • Drug: Placebo oral capsules
    Daily dose
Study Arms  ICMJE
  • Experimental: Active Treatment
    PRC-063 25, 35, 45, 55, 70, 85, or 100 mg
    Intervention: Drug: PRC-063 oral capsules
  • Placebo Comparator: Placebo Treatment
    Matched placebo
    Intervention: Drug: Placebo oral capsules
Publications * Childress A, Cutler AJ, Marraffino AH, Bhaskar S, Donnelly G. Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adult Laboratory Classroom Study of the Efficacy and Safety of PRC-063 (Extended-Release Methylphenidate) for the Treatment of ADHD. J Atten Disord. 2021 Jun 30:10870547211025610. doi: 10.1177/10870547211025610. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2019)
288
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
250
Actual Study Completion Date  ICMJE July 5, 2019
Actual Primary Completion Date July 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03618030
Other Study ID Numbers  ICMJE 063-020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Purdue Pharma, Canada
Study Sponsor  ICMJE Purdue Pharma, Canada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sailaja Bhaskar, PhD Purdue Pharma, Canada
PRS Account Purdue Pharma, Canada
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP