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



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:31 - 80
Updated:12/7/2017
Start Date:October 2006
End Date:November 2008

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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.


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.
We found this trial at
1
site
6550 Fannin Street
Houston, Texas 77030
?
mi
from
Houston, TX
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