drugset

drugset / Trial / NCT00974974

A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

NCT00974974 ↗

Phase 3 Completed 471 enrolled Impax Laboratories, LLC

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.

Timeline

Start: 2009-09
Primary completion: 2011-01
Completion: 2011-03

Publications

Morgan JC, Dhall R, Rubens R, Khanna S, Gupta S. Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson's Disease with Motor Fluctuations. Parkinsons Dis. 2018 Oct 22;2018:9763057. doi: 10.1155/2018/9763057. eCollection 2018.
Hauser RA, Hsu A, Kell S, Espay AJ, Sethi K, Stacy M, Ondo W, O'Connell M, Gupta S; IPX066 ADVANCE-PD investigators. Extended-release carbidopa-levodopa (IPX066) compared with immediate-release carbidopa-levodopa in patients with Parkinson's disease and motor fluctuations: a phase 3 randomised, double-blind trial. Lancet Neurol. 2013 Apr;12(4):346-56. doi: 10.1016/S1474-4422(13)70025-5. Epub 2013 Feb 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levodopa	Small molecule	—	Oral

Indications