Trials / Completed
CompletedNCT01130493
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Impax Laboratories, LLC · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.
Detailed description
This is a randomized, double-blind, double-dummy, 2 treatment, 2-period crossover study followed by an open-label extension study period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IPX066 | experimental product |
| DRUG | CLE | active comparator |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2012-01-01
- Completion
- 2012-01-01
- First posted
- 2010-05-26
- Last updated
- 2019-10-29
- Results posted
- 2017-09-13
Locations
24 sites across 4 countries: United States, France, Germany, Italy
Source: ClinicalTrials.gov record NCT01130493. Inclusion in this directory is not an endorsement.