Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Crossover Assignment, Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: Parcopa
  • at subjects current stable dose of comparator
• Drug: carbidopa-levodopa
  • at subjects current stable dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: b
  • Parcopa at equivalent dosage to subjects surrent stable dose
• Active Comparator: a
  • carbidopa-levodopa at subjects current stable dose

Primary Measures

• time to on
  • Time Frame: first dose of day for each arm
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 31 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Baylor College of Medicine

Overall Clinical Trial Officials and Contacts

William G Ondo, MD Principal Investigator Baylor College of Medicine  

Overall Contact: Lina Shinawi, CCRC 713-798-5519 lshinawi@bcm.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00590122

Study ID Number: H-19596

ClinicalTrials.gov Identifier: NCT00590122

Health Authority: United States: Institutional Review Board