Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study
Information source: Baylor College of Medicine
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: Parcopa (Drug); carbidopa-levodopa (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Baylor College of Medicine Official(s) and/or principal investigator(s):
William G Ondo, MD, Principal Investigator, Affiliation: Baylor College of Medicine
Overall contact:
Lina Shinawi, CCRC, Phone: 713-798-5519, Email: lshinawi@bcm.edu
Summary
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.
Clinical Details
Official title: COMPARISON OF ORALLY DISSOLVING LEVODOPA (PARCOPA®) TO CONVENTIONAL ORAL LEVODOPA: A SINGLE DOSE, DOUBLE-BLIND, PLACEBO CONTROLLED, CROSS-OVER TRIAL
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Crossover Assignment, Efficacy Study
Primary outcome: time to on
Eligibility
Minimum age: 31 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Lina Shinawi, CCRC, Phone: 713-798-5519, Email: lshinawi@bcm.edu
PDCMDC 6550 Fannin, Suite 1801, Houston, Texas 77030, United States; Recruiting
William G Ondo, MD, Principal Investigator
Additional Information
Starting date: October 2006
Ending date: April 2008
Last updated: January 9, 2008
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