Trials / Completed
CompletedNCT00974974
A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 471 (actual)
- Sponsor
- Impax Laboratories, LLC · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.
Detailed description
A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will enter a 3-week dose-adjustment period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IPX066 | extended-release carbidopa-levodopa capsules |
| DRUG | IR CD-LD | immediate-release carbidopa-levodopa tablets |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2011-01-01
- Completion
- 2011-03-01
- First posted
- 2009-09-11
- Last updated
- 2020-08-11
- Results posted
- 2016-01-14
Locations
73 sites across 8 countries: United States, Canada, France, Germany, Poland, Romania, Spain, Ukraine
Source: ClinicalTrials.gov record NCT00974974. Inclusion in this directory is not an endorsement.