A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease

NCT00880620 ↗

Phase 3 Completed 381 enrolled Impax Laboratories, LLC

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.

Timeline

Start: 2009-04
Primary completion: 2010-10
Completion: 2010-11

Outcome

Met primary endpoint

release “The trial met its primary efficacy endpoint of change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III score at end of study.” amneal.com ↗

release “In APEX-PD, a trial that enrolled and randomized 381 levodopa-naive patients, the study met its primary efficacy endpoint” amneal.com ↗

Publications

Background Pahwa R, Lyons KE, Hauser RA, Fahn S, Jankovic J, Pourcher E, Hsu A, O'Connell M, Kell S, Gupta S; APEX-PD Investigators. Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease. Parkinsonism Relat Disord. 2014 Feb;20(2):142-8. doi: 10.1016/j.parkreldis.2013.08.017. Epub 2013 Sep 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IPX066	Unknown	145 mg	—
Subject	IPX066	Unknown	245 mg	—
Subject	IPX066	Unknown	390 mg	—