PRC-063 in Adolescent ADHD

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 adolescents with ADHD.

Timeline

Start

2014-04

Primary completion

2015-03

Completion

2015-05

Publications

• Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2025 Dec 4;12(12):CD009885. doi: 10.1002/14651858.CD009885.pub4.
• Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.
• Weiss MD, Surman C, Khullar A, Owens J, He E, Cataldo M, Donnelly G. Effect of a Multilayer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adolescents with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial Followed by a 6-Month Open-Label Follow-Up. J Child Adolesc Psychopharmacol. 2021 Nov;31(9):623-630. doi: 10.1089/cap.2021.0087. Epub 2021 Oct 28.
• Weiss MD, Cutler AJ, Kollins SH, Donnelly GAE. Efficacy and Safety of a Long-Acting Multilayer-Release Methylphenidate Formulation (PRC-063) in the Treatment of Adolescent Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind Clinical Trial with a 6-Month Open-Label Extension. J Child Adolesc Psychopharmacol. 2021 Nov;31(9):610-622. doi: 10.1089/cap.2021.0034. Epub 2021 Oct 8.

Drugs

Indications