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Clinical Trials/NCT00139880
NCT00139880
Completed
Phase 3

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

UCB Pharma1 site in 1 countryJune 2005

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
UCB Pharma
Locations
1
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Detailed Description

See approved Package Insert for Adverse Event information.

Registry
clinicaltrials.gov
Start Date
June 2005
End Date
August 2005
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
UCB Pharma

Eligibility Criteria

Inclusion Criteria

  • Stable Parkinson's disease

Exclusion Criteria

  • idiopathic PD with Hoehn and Yahr state II or III

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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