Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Phase 3 Completed 45 enrolled Pfizer

RandomizedCrossoverTriple-blindTreatment

Summary

The objective of this study was to establish that an optimal dose of Quillivant XR oral suspension would result in a significant reduction in signs and symptoms of ADHD compared to placebo treatment in pediatric patients ages 6-12 years with ADHD.

Timeline

Start: 2009-04
Primary completion: 2009-08
Completion: 2009-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); NWP06 vs Placebo; p <0.0001; Least Square (LS) mean difference -12.46 (95% CI -14.75 to -10.17); ANOVA NCT00904670 ↗

Publications

Wigal SB, Childress AC, Belden HW, Berry SA. NWP06, an extended-release oral suspension of methylphenidate, improved attention-deficit/hyperactivity disorder symptoms compared with placebo in a laboratory classroom study. J Child Adolesc Psychopharmacol. 2013 Feb;23(1):3-10. doi: 10.1089/cap.2012.0073. Epub 2013 Jan 5.

Drugs

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