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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: Completed Phase 2 study, sponsored by XenoPort.
NCT01171313 is a Phase 2 study that has completed, run by XenoPort. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01171313 record still lists
NCT01171313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 4 interventions - of which XP21279 and carbidopa (experimental) is the first listed.
NCT01171313 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01171313's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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