drugset / Trial / NCT02139124
The Efficacy and Safety of PRC-063 in Adult ADHD Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adults with ADHD
Timeline
- Start
- 2014-04
- Primary completion
- 2014-10
- Completion
- 2015-01
Publications
- Weiss MD, Newcorn JH, Chokka P, Cataldo M, Bhaskar S, Donnelly GAE. An Exploratory Study of Functional Outcome in Stimulant Treatment of ADHD in Adults. J Atten Disord. 2026 May 5:10870547261440452. doi: 10.1177/10870547261440452. Online ahead of print.
- Weiss MD, Surman C, Khullar A, He E, Cataldo M, Donnelly G. Effect of a Multi-Layer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adults with ADHD: A Randomized, Double-Blind, Forced-Dose, Placebo-Controlled Trial Followed by a 6-month Open-Label Extension. CNS Drugs. 2021 Jun;35(6):667-679. doi: 10.1007/s40263-021-00814-z. Epub 2021 May 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylphenidate | Small molecule | 25 mg | Oral |
| Subject | Methylphenidate | Small molecule | 45 mg | Oral |
| Subject | Methylphenidate | Small molecule | 70 mg | Oral |
| Subject | Methylphenidate | Small molecule | 100 mg | Oral |