Comparison of Orally Dissolving Carbidopa/Levodopa (Parcopa) to Conventional Oral Carbidopa/Levodopa: A Single-Dose, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Trial
Overview
- Phase
- Phase 4
- Intervention
- Parcopa
- Conditions
- Parkinson's Disease
- Sponsor
- Baylor College of Medicine
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Detailed Description
This is a study to compare orally dissolving levodopa (Parcopa) to the conventional immediate release oral levodopa. This is a single-dose, double-blind, placebo controlled crossover trial in participants with Parkinson disease.
Investigators
Joseph Jankovic
Principal Investigator
Baylor College of Medicine
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
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.
Arms & Interventions
Randomization Group b
Parcopa at equivalent dosage to subjects current stable dose
Intervention: Parcopa
Randomization Group a
Carbidopa-levodopa (Sinemet)at subjects current stable dose
Intervention: carbidopa-levodopa (Sinemet)
Outcomes
Primary Outcomes
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
Time Frame: first dose of day for each arm
Time to "on" state (benefit with regard to mobility, stiffness and slowness) with parcopa versus carbidopa/levodopa immediate release compound. This measurement is compared between Parcopa and carbidopa/levodopa wit the first morning dose of each intervention. Study duration was 2 days.