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Completed

NCT Number: NCT03618030

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

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Meridien Research Inc., Bradenton, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Primary and/or comorbid psychiatric diagnosis other than ADHD
  • 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;
  • Has used any investigational drug within 30 days of the screening visit;

Treatment and study plan

PRC-063 oral capsules

Drug

Daily dose

Placebo oral capsules

Drug

Daily dose

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Purdue Pharma, Canada

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2018
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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