Trials / Completed
CompletedNCT01171313
A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects
A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- XenoPort, Inc. · Industry
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after administration of XP21279/Carbidopa and Sinemet and to explore exposure-response relationships in a subset of subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XP21279 and carbidopa (experimental) | Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa |
| DRUG | Sinemet (comparator) | Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet. |
| DRUG | Placebo for XP21279 and carbidopa | Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa |
| DRUG | Placebo for Sinemet | Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2011-10-01
- Completion
- 2011-12-01
- First posted
- 2010-07-28
- Last updated
- 2021-02-18
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01171313. Inclusion in this directory is not an endorsement.