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

Sponsor

Baylor College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00590122

Collaborator

UCB Pharma (Industry)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Parcopa Drug: carbidopa-levodopa	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

COMPARISON OF ORALLY DISSOLVING LEVODOPA (PARCOPA®) TO CONVENTIONAL ORAL LEVODOPA: A SINGLE DOSE, DOUBLE-BLIND, PLACEBO CONTROLLED, CROSS-OVER TRIAL

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: b Parcopa at equivalent dosage to subjects surrent stable dose	Drug: Parcopa at subjects current stable dose of comparator
Active Comparator: a carbidopa-levodopa at subjects current stable dose	Drug: carbidopa-levodopa at subjects current stable dose Other Names: Sinemet

Arm

Intervention/Treatment

Experimental: b

Parcopa at equivalent dosage to subjects surrent stable dose

Drug: Parcopa

at subjects current stable dose of comparator

Active Comparator: a

carbidopa-levodopa at subjects current stable dose

Drug: carbidopa-levodopa

at subjects current stable dose

Other Names:

Sinemet

Outcome Measures

Primary Outcome Measures

time to on [first dose of day for each arm]

Eligibility Criteria

Criteria

Ages Eligible for Study:

31 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Hormonal contraceptives
Spermicidal and barrier
Intrauterine device
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.