At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 617 enrolled
Drug / intervention
IPX066 95 mg +3 moredrug
Likely dose
IPX066 95 mgfrom 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.
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
In Brief
A Phase 3 clinical trial evaluating IPX066 95 mg, IPX066 145 mg, and 2 other interventions for Parkinson's Disease. Completed, enrolled 617 participants across 81 sites in 10 countries.
Detailed Summary
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesCanada, Estonia, Germany, Latvia, Lithuania, Poland, Romania, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionOct 2011
TodayJul 2026
First PostedMar 31, 2010
Enrollment StartMar 1, 2010
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.3 years ago
Interventions
IPX066 95 mgdrug
23.75 - 95 mg CD-LD capsules
IPX066 145 mgdrug
36.25 - 145 mg CD-LD capsules
IPX066 195 mgdrug
48.75 - 195 mg CD-LD capsules
IPX066 245 mgdrug
61.25 - 245 mg CD-LD capsules