Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

Phase 3 Completed 725 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupTriple-blindTreatment

Summary

This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).

Timeline

Start: 2010-11
Primary completion: 2012-08
Completion: 2012-08

Publications

Huss M, Ginsberg Y, Tvedten T, Arngrim T, Philipsen A, Carter K, Chen CW, Kumar V. Methylphenidate hydrochloride modified-release in adults with attention deficit hyperactivity disorder: a randomized double-blind placebo-controlled trial. Adv Ther. 2014 Jan;31(1):44-65. doi: 10.1007/s12325-013-0085-5. Epub 2013 Dec 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylphenidate	Small molecule	40 mg	Oral
Subject	Methylphenidate	Small molecule	60 mg	Oral
Subject	Methylphenidate	Small molecule	80 mg	Oral

Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

Summary

Timeline

Publications

Drugs

Indications