A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease

September 3, 2013 updated by: UCB Pharma
To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are eligible if taking a stable dose of < 200 mg carbidopa and < 2000 mg levodopa daily. At both treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or conventional) are administered. The dose is the same as the subject's prestudy regimen. The primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by a rater blinded to the active treatment received by the subject.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See approved Package Insert for Adverse Event information.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Schwarz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable Parkinson's disease

Exclusion Criteria:

  • idiopathic PD with Hoehn and Yahr state II or III

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 3, 2013

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP867

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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