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A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects

NCT01171313 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-02-18

No results posted yet for this 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • XenoPort, Inc.

    lead INDUSTRY

Principal Investigators

  • Dan Chen, M.D. · XenoPort, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01171313 on ClinicalTrials.gov