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

July 2, 2021 updated by: Purdue Pharma, Canada

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bradenton, Florida, United States, 34201
        • Meridien Research Inc.
      • Lakeland, Florida, United States, 33805
        • Meridien Research
      • Maitland, Florida, United States, 32751
        • Meridien Research Inc.
    • Massachusetts
      • Hingham, Massachusetts, United States, 02043
        • South Shore Psychiatric Services
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Center For Psychiatry And Behavioral Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Center For Psychiatry And Behavioral Medicine
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17004
        • Penn State Health Milton S. Hershey Medical Center
    • Texas
      • Houston, Texas, United States, 77007
        • Bayou City Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Full-day ALC - 13 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue Pharma, Canada

Investigators

  • Study Director: Sailaja Bhaskar, PhD, Purdue Pharma, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2018

Primary Completion (Actual)

July 5, 2019

Study Completion (Actual)

July 5, 2019

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 063-020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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