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.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00139880
First received: August 29, 2005
Last updated: September 3, 2013
Last verified: September 2009

August 29, 2005
September 3, 2013
June 2005
August 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00139880 on ClinicalTrials.gov Archive Site
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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
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

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.

See approved Package Insert for Adverse Event information.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Parkinson's Disease
Drug: Parcopa
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2005
August 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stable Parkinson's disease

Exclusion Criteria:

  • idiopathic PD with Hoehn and Yahr state II or III
Both
40 Years and older
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00139880
SP867
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UCB Pharma
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Study Director: UCB Clinical Trial Call Center UCB Pharma
UCB Pharma
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP