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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.

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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

FieldValue
Enrollment Target 35 participants
Start Date 2010-07
Est. Completion 2011-12
Phase Phase 2

Sponsor

XenoPort

19 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.