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

ADHD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618030
• Other study ID #: 063-020
• Status: Completed
• Phase: Phase 3
• Start date: August 21, 2018
• Est. completion date: July 5, 2019

Study information

• Verified date: July 2021
• Source: Purdue Pharma, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: July 5, 2019
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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;

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• PRC-063 oral capsules
Daily dose
• Placebo oral capsules
Daily dose

Locations

Country	Name	City	State
United States	Meridien Research Inc.	Bradenton	Florida
United States	Center for Psychiatry and Behavioral Medicine	Durham	North Carolina
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	South Shore Psychiatric Services	Hingham	Massachusetts
United States	Bayou City Research	Houston	Texas
United States	Meridien Research	Lakeland	Florida
United States	Center for Psychiatry and Behavioral Medicine	Las Vegas	Nevada
United States	Meridien Research Inc.	Maitland	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma, Canada

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit	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