NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Phase 3 Completed 90 enrolled Pfizer

RandomizedQuadruple-blindTreatment

Summary

The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD

Timeline

Start: 2012-07
Primary completion: 2012-10
Completion: 2012-10

Outcome

Met primary endpoint

paper MPH ERCT treatment statistically significantly reduced the average of all postdose SKAMP-Combined scores versus placebo (least-squares mean difference [95% confidence interval], -7.0 [-10.9, -3.1]; p < 0.001). PMID 28557548 ↗

Publications

Wigal SB, Childress A, Berry SA, Belden H, Walters F, Chappell P, Sherman N, Orazem J, Palumbo D. Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2017 Oct;27(8):690-699. doi: 10.1089/cap.2016.0177. Epub 2017 May 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylphenidate	Small molecule	20 mg	—
Subject	Methylphenidate	Small molecule	60 mg	—