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

Completed · Phase 3 · Has a placebo group

Conditions studied: ADHD

In brief

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

Key facts

Study ID

NCT03618030

Run by

Purdue Pharma, Canada

People needed

288

Starts

2018-08-21

Expected to finish

2019-07-05

Last updated by the study team

2021-07-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Meridien Research Inc. — Bradenton, Florida, United States
• Meridien Research — Lakeland, Florida, United States
• Meridien Research Inc. — Maitland, Florida, United States
• South Shore Psychiatric Services — Hingham, Massachusetts, United States
• Center for Psychiatry and Behavioral Medicine — Las Vegas, Nevada, 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
• Bayou City Research — Houston, Texas, United States

Full record on ClinicalTrials.gov

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