Phase 3
Completed N=288
PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT03618030 ↗Enrolled (actual)
288
Serious AEs
0.2%
Results posted
Jul 2021
Primary outcomePrimary: Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit — 302.9; 286.6 score on a scale — p=.0003
◆ Published Evidence
Emerging
9citations · ~2 / year
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.
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
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit |
302.9; 286.6 | .0003 sig |
Eligibility Criteria
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;
Data sourced from ClinicalTrials.gov (NCT03618030) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.