PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT ID: NCT03618030
Last Updated: 2021-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
288 participants
INTERVENTIONAL
2018-08-21
2019-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Active Treatment
PRC-063 25, 35, 45, 55, 70, 85, or 100 mg
PRC-063 oral capsules
Daily dose
Placebo Treatment
Matched placebo
Placebo oral capsules
Daily dose
Interventions
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PRC-063 oral capsules
Daily dose
Placebo oral capsules
Daily dose
Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
60 Years
ALL
No
Sponsors
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Purdue Pharma, Canada
INDUSTRY
Responsible Party
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Principal Investigators
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Sailaja Bhaskar, PhD
Role: STUDY_DIRECTOR
Purdue Pharma, Canada
Locations
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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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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063-020
Identifier Type: -
Identifier Source: org_study_id
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