Back to resultsParcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Parcopa
carbidopa-levodopa (Sinemet)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, time to "on", delayed on
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.
Sites / Locations
- PDCMDC 6550 Fannin, Suite 1801
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Randomization Group b
Randomization Group a
Arm Description
Parcopa at equivalent dosage to subjects current stable dose
Carbidopa-levodopa (Sinemet)at subjects current stable dose
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00590122
First Posted
December 28, 2007
Last Updated
February 16, 2023
Sponsor
Baylor College of Medicine
Collaborators
UCB Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00590122
Brief Title
Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study
Official Title
Comparison of Orally Dissolving Carbidopa/Levodopa (Parcopa) to Conventional Oral Carbidopa/Levodopa: A Single-Dose, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, time to "on", delayed on
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Randomization Group b
Arm Type
Experimental
Arm Description
Parcopa at equivalent dosage to subjects current stable dose
Arm Title
Randomization Group a
Arm Type
Active Comparator
Arm Description
Carbidopa-levodopa (Sinemet)at subjects current stable dose
Intervention Type
Drug
Intervention Name(s)
Parcopa
Intervention Description
at subjects current stable dose of comparator
Intervention Type
Drug
Intervention Name(s)
carbidopa-levodopa (Sinemet)
Intervention Description
at subjects current stable dose
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
first dose of day for each arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William G Ondo, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
PDCMDC 6550 Fannin, Suite 1801
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20925074
Citation
Ondo WG, Shinawi L, Moore S. Comparison of orally dissolving carbidopa/levodopa (Parcopa) to conventional oral carbidopa/levodopa: A single-dose, double-blind, double-dummy, placebo-controlled, crossover trial. Mov Disord. 2010 Dec 15;25(16):2724-7. doi: 10.1002/mds.23158.
Results Reference
background
Learn more about this trial
Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study
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