CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 381 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
IPX066 95 mg LDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00880620
NCT00880620Phase 3Completed

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

Impax Laboratories, LLC·interventional·Posted Apr 14, 2009·Updated Oct 29, 2019

In Brief

A Phase 3 clinical trial evaluating Placebo, IPX066 95 mg LD, and 3 other interventions for Parkinson's Disease. Completed, enrolled 381 participants across 60 sites in 7 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Estonia, Latvia, Lithuania, Romania, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 14, 2009
Enrollment StartApr 1, 2009
Primary CompletionOct 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.2 years ago

Interventions

Placebodrug

Placebo

IPX066 95 mg LDdrug

IPX066 capsule containing 95 mg LD/23.75 mg CD

IPX066 145 mg LDdrug

IPX066 capsule containing 145 mg LD/36.25 mg CD

IPX066 195 mg LDdrug

IPX066 capsule containing 195 mg LD/48.75 mg CD

IPX066 245 mg LDdrug

IPX066 capsule containing 245 mg LD/61.25 mg CD