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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
This study has been completed.
First Received: August 29, 2005   Last Updated: April 16, 2008   History of Changes
Sponsored by: UCB
Information provided by: UCB
ClinicalTrials.gov Identifier: NCT00139880
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: Parcopa
Phase III

Study Type: Interventional
Study Design: Randomized, Double-Blind, Dose Comparison, Crossover Assignment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB:

Study Start Date: June 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Detailed Description:

See approved Package Insert for Adverse Event information.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Stable Parkinson's disease

Exclusion Criteria:

  • idiopathic PD with Hoehn and Yahr state II or III
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139880

Locations
United States, Wisconsin
Schwarz
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
UCB
Investigators
Study Director: Patricia Witt UCB
  More Information

No publications provided

Study ID Numbers: SP867
Study First Received: August 29, 2005
Last Updated: April 16, 2008
ClinicalTrials.gov Identifier: NCT00139880     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Ganglion Cysts
Movement Disorders
Parkinson Disease
Sinemet
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on July 02, 2009