Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: UCB Pharma
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

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.