A Safety and Effectiveness Study of Methylphenidate HCl Extended-release Tablets in Adults With Attention Deficit Hyperactivity Disorder

Phase 3 Completed 229 enrolled McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness and safety of methylphenidate HCl extended-release tablets at five dose levels compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Start: 2006-04
Primary completion: 2006-12
Completion: 2006-12

Outcome

Met primary endpoint

paper Adult ADHD Investigator Symptom Report Scale total score at the final visit (last observation carried forward [LOCF]; P = 0.012). PMID 19440077 ↗

Publications

Adler LA, Zimmerman B, Starr HL, Silber S, Palumbo J, Orman C, Spencer T. Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study. J Clin Psychopharmacol. 2009 Jun;29(3):239-47. doi: 10.1097/JCP.0b013e3181a390ce.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylphenidate	Small molecule	36 mg	Oral
Subject	Methylphenidate	Small molecule	54 mg	Oral
Subject	Methylphenidate	Small molecule	72 mg	Oral
Subject	Methylphenidate	Small molecule	90 mg	Oral
Subject	Methylphenidate	Small molecule	108 mg	Oral