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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-08-31

Brief Summary

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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

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See approved Package Insert for Adverse Event information.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Interventions

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Parcopa

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stable Parkinson's disease

Exclusion Criteria

* idiopathic PD with Hoehn and Yahr state II or III

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Locations

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Schwarz

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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SP867

Identifier Type: -

Identifier Source: org_study_id