MedTrace Logo

An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects

NCT00914602 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-05-05

No results posted yet for this study

Summary

The purpose of the study is to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation \[administered with Lodosyn® (carbidopa)\] and Sinemet® tablets in subjects with Parkinson's disease with Motor Fluctuations.

Conditions

Interventions

DRUG

Sinemet 25-100 Oral Tablet

After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days.

DRUG

XP21279

Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®).

DRUG

Carbidopa Pill

Sponsors & Collaborators

  • XenoPort, Inc.

    lead INDUSTRY

Principal Investigators

  • Steve D Caras, MD · Arbor Pharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-01-31
Completion
2010-01-31

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 NCT00914602 on ClinicalTrials.gov