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 |
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.
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.
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