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Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study
This study has been completed.
Study NCT00590122   Information provided by Baylor College of Medicine
First Received: December 28, 2007   Last Updated: March 12, 2009   History of Changes

December 28, 2007
March 12, 2009
October 2006
October 2008   (final data collection date for primary outcome measure)
time to on [ Time Frame: first dose of day for each arm ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00590122 on ClinicalTrials.gov Archive Site
 
 
 
Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study
COMPARISON OF ORALLY DISSOLVING LEVODOPA (PARCOPA®) TO CONVENTIONAL ORAL LEVODOPA: A SINGLE DOSE, DOUBLE-BLIND, PLACEBO CONTROLLED, CROSS-OVER TRIAL

To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Crossover Assignment, Efficacy Study
Parkinson's Disease
  • Drug: Parcopa
  • Drug: carbidopa-levodopa
  • Experimental: Parcopa at equivalent dosage to subjects surrent stable dose
  • Active Comparator: carbidopa-levodopa at subjects current stable dose
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
20
November 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female between the age of 31 and 80 -Diagnosis of idiopathic Parkinson's disease for at least three years duration
  • Patients requiring levodopa for their PD
  • Good subjective response to levodopa
  • Fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose failures
  • A UPDRS -off- motor score of at least 25
  • Subjects willing to give informed consent
  • Subjects who are able and willing to comply with study procedures
  • If female of child-bearing potential, will use one of the approved birth control measures:

    1. Hormonal contraceptives
    2. Spermicidal and barrier
    3. Intrauterine device
    4. Partner sterility

Exclusion Criteria:

  • Subjects with evidence of significant dementia
  • Subjects with significant oral lesions
  • History of unstable cardiac disease including angina or congestive heart failure within 3 months prior to study entry
  • History of clinically significant renal disease including renal insufficiency of sufficient degree to require adjunctive treatment or dietary restrictions
  • History of clinically significant hepatic disease, including previously documented cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry.
  • Subjects with poor response to levodopa
  • Women who are pregnant, breast-feeding, or planning to become pregnant during this study are excluded from participation due to unknown effects of the study drug on the fetus.
Both
31 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00590122
William G. Ondo, MD, Baylor College of Medicine
H-19596
Baylor College of Medicine
UCB, Inc.
Principal Investigator: William G Ondo, MD Baylor College of Medicine
Baylor College of Medicine
March 2009

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