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

Phase 3

Completed

• Conditions: ADHD
• Interventions: Drug: Placebo oral capsules; Drug: PRC-063 oral capsules

• Registration Number: NCT03618030
• Lead Sponsor: Purdue Pharma, Canada

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 available

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-07
• Study Start: 2018-08-21
• Primary Completion: 2019-07-05
• Study Completion: 2019-07-05
• Results First Submitted: 2020-10-29
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-02
• Last Update Submitted: 2021-07-02
• Results First Posted: 2021-07-26
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Treatment	Placebo oral capsules	Matched placebo
Active Treatment	PRC-063 oral capsules	PRC-063 25, 35, 45, 55, 70, 85, or 100 mg

Primary Outcome Measures

Name	Time	Method
Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit	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.

Trial Locations

Locations (6)

Bayou City Research; 🇺🇸 Houston, Texas, United States

Penn State Health Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Meridien Research; 🇺🇸 Lakeland, Florida, United States

South Shore Psychiatric Services; 🇺🇸 Hingham, Massachusetts, United States

Meridien Research Inc.; 🇺🇸 Maitland, Florida, United States

Center for Psychiatry and Behavioral Medicine; 🇺🇸 Durham, North Carolina, United States