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Trial record 1 of 1 for:    NCT00139880
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00139880
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : September 4, 2013
Sponsor:
Information provided by:
UCB Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Parcopa Phase 3

Detailed Description:
See approved Package Insert for Adverse Event information.
Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : June 2005
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Stable Parkinson's disease

Exclusion Criteria:

  • idiopathic PD with Hoehn and Yahr state II or III
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139880


Locations
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United States, Wisconsin
Schwarz
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information
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ClinicalTrials.gov Identifier: NCT00139880    
Other Study ID Numbers: SP867
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2009
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Carbidopa, levodopa drug combination
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action