Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting

Summary

The time course of response following one dose of a new methylphenidate hydrochloride extended release capsule is studied in children 6-12 years in a simulated laboratory classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been formulated for daily dosing to provide treatment of a child with Attention deficit hyperactivity disorder (ADHD) for the substantial day.

Timeline

Start

2011-01-19

Primary completion

2011-06-18

Completion

2013-03-13

Outcome

Met primary endpoint

registry analysis (unspecified test); Methylphenidate HCl ER Capsules vs Capsule Without Active Drug; p <0.01; ANCOVA NCT01269463 ↗

paper The least-squares mean postdose SKAMP-Total score was higher for placebo than for MPH-MLR (2.18 vs. 1.32, respectively; p=0.0001), PMID 25470572 ↗

paper indicating fewer symptoms with MPH-MLR therapy than with placebo. PMID 25470572 ↗

Publications

• Wigal SB, Greenhill LL, Nordbrock E, Connor DF, Kollins SH, Adjei A, Childress A, Stehli A, Kupper RJ. A randomized placebo-controlled double-blind study evaluating the time course of response to methylphenidate hydrochloride extended-release capsules in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2014 Dec;24(10):562-9. doi: 10.1089/cap.2014.0100.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylphenidate	Small molecule	15 mg	—
Subject	Methylphenidate	Small molecule	20 mg	—
Subject	Methylphenidate	Small molecule	30 mg	—
Subject	Methylphenidate	Small molecule	40 mg	—

Indications