drugset / Trial / NCT01130493

A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066

NCT01130493 ↗

Phase 3 Completed 110 enrolled Impax Laboratories, LLC
RandomizedCrossoverQuadruple-blindTreatment

Summary

This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.

Timeline

Start
2010-05
Primary completion
2012-01
Completion
2012-01

Outcome

Met primary endpoint

release “IPX066 demonstrated statistically significant improvement over carbidopa-levodopa plus entacapone in reducing the percentage of "off time" during waking hours” amneal.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject CLE Unknown — —
Subject IPX066 Unknown — Oral

Indications