Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD

Summary

This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.

Timeline

Start

2010-11

Primary completion

2012-02

Completion

2012-03

Outcome

Met primary endpoint

registry analysis (unspecified test); 10 mg vs 15 mg vs 20 mg vs 40 mg vs Placebo; p = 0.0046; ANCOVA NCT01239030 ↗

Publications

• Wigal SB, Nordbrock E, Adjei AL, Childress A, Kupper RJ, Greenhill L. Efficacy of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Phase III, Randomized, Double-Blind Study. CNS Drugs. 2015 Apr;29(4):331-40. doi: 10.1007/s40263-015-0241-3.

Drugs

Indications