Phase 4
Completed N=20
Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study
Source: ClinicalTrials.gov NCT00590122 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Measurement of Time in Minutes From When a Patient Was in a Clinical "Off" State, Took Their Medication and Went Into a Clinical "on" State — 23.9; 28.5 minutes
◆ Published Evidence
Established
25citations · ~2 / year
Comparison of orally dissolving carbidopa/levodopa (Parcopa) to conventional oral carbidopa/levodopa: A single-dose, double-blind, double-dummy, placebo-controlled, crossover trial.
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.
Linked Publications
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Comparison of orally dissolving carbidopa/levodopa (Parcopa) to conventional oral carbidopa/levodopa: A single-dose, double-blind, double-dummy, placebo-controlled, crossover trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Time in Minutes From When a Patient Was in a Clinical "Off" State, Took Their Medication and Went Into a Clinical "on" State |
23.9; 28.5 | — |
Eligibility 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:
- 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.
Data sourced from ClinicalTrials.gov (NCT00590122) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.