Lab School Day Study for CONCERTA of Older Children With ADHD

Phase 4 Completed 78 enrolled Ortho-McNeil Janssen Scientific Affairs, LLC

RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with attention deficit hyperactivity disorder (ADHD), when compared to placebo.

Timeline

Start: 2008-12
Primary completion: 2009-06
Completion: 2009-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Concerta; p <0.0001; LS Mean Difference -28.6 (95% CI -35.0 to -22.3); Mixed Models Analysis NCT00799409 ↗

registry analysis (superiority or other test); Placebo vs Concerta; p <0.0001; LS Mean Difference -28.3 (95% CI -34.4 to -22.2); Mixed Models Analysis NCT00799409 ↗

Publications

Wigal SB, Wigal T, Schuck S, Brams M, Williamson D, Armstrong RB, Starr HL. Academic, behavioral, and cognitive effects of OROS(R) methylphenidate on older children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2011 Apr;21(2):121-31. doi: 10.1089/cap.2010.0047. Epub 2011 Apr 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylphenidate	Small molecule	18 mg	Oral
Subject	Methylphenidate	Small molecule	54 mg	Oral