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NCT01171313 · ClinicalTrials.gov registry record · Phase 2
A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects
A Phase 2 study, sponsored by XenoPort.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT01171313 is a Phase 2 study that has completed, run by XenoPort. The registered enrollment target is 35 participants.
The verdict
NCT01171313, a Phase 2 study, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study 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.
Interventions
- DRUG XP21279 and carbidopa (experimental)
- DRUG Sinemet (comparator)
- DRUG Placebo for XP21279 and carbidopa
- DRUG Placebo for Sinemet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01171313
The ClinicalTrials.gov registry entry for NCT01171313 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is XenoPort, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which XP21279 and carbidopa (experimental) is the first listed.
NCT01171313 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01171313 about?
NCT01171313 is a clinical study titled "A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects". 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.
What is the current status of trial NCT01171313?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2010-07. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01171313?
The interventions under investigation include: XP21279 and carbidopa (experimental) (DRUG), Sinemet (comparator) (DRUG), Placebo for XP21279 and carbidopa (DRUG), Placebo for Sinemet (DRUG).
Who is sponsoring clinical trial NCT01171313?
This trial is sponsored by XenoPort, which has 19 total clinical trials registered on ClinicalTrials.gov.
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