Clinical trial NCT03618030: PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Lead sponsor: Purdue Pharma, Canada
Sponsor class: INDUSTRY
First posted: 2018-08-07
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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;

Primary outcomes:
measure: Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit
timeFrame: Full-day ALC - 13 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Meridien Research Inc.
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Maitland
country: United States
facility: Meridien Research Inc.
state: Florida
city: Hingham
country: United States
facility: South Shore Psychiatric Services
state: Massachusetts
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine
state: Nevada
city: Durham
country: United States
facility: Center for Psychiatry and Behavioral Medicine
state: North Carolina
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Bayou City Research
state: Texas
Study officials:
affiliation: Purdue Pharma, Canada
name: Sailaja Bhaskar, PhD
role: STUDY_DIRECTOR
References:
citation: Childress A, Cutler AJ, Marraffino AH, Bhaskar S, Donnelly G. Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adult Laboratory Classroom Study of the Efficacy and Safety of PRC-063 (Extended-Release Methylphenidate) for the Treatment of ADHD. J Atten Disord. 2022 Apr;26(6):857-869. doi: 10.1177/10870547211025610. Epub 2021 Jun 30.