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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomization Group b | Experimental | Parcopa at equivalent dosage to subjects current stable dose |
|
| Randomization Group a | Active Comparator | Carbidopa-levodopa (Sinemet)at subjects current stable dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parcopa | Drug | at subjects current stable dose of comparator |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | first dose of day for each arm |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William G Ondo, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PDCMDC 6550 Fannin, Suite 1801 | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20925074 | Background | 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. |
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Crossover study design
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| ID | Title | Description |
|---|---|---|
| FG000 | B-Parcopa Arm First Then Crossover to Carbidopa/Levodopa Arm | Parcopa: at subjects current stable dose of comparator first (Day 1) then crossover to the carbidopa/levodopa arm (Day 2) |
| FG001 | A-Carbidopa/Levodopa Arm Then Crossover to Parcopa Arm | carbidopa-levodopa at subjects current stable dose (Day 1) then crossover to the parcopa comparator arm of the study (Day 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Crossover design study total number same in each group
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| ID | Title | Description |
|---|---|---|
| BG000 | B-Parcopa Arm First Then Crossover to Carbidopa/Levodopa Arm | Parcopa: at subjects current stable dose of comparator |
| BG001 | A-Carbidopa/Levodopa Arm Then Crossover to Parcopa Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | minutes | first dose of day for each arm |
|
2 day, double blind crossover study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | B-Parcopa Arm | Parcopa: at subjects current stable dose of comparator | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dyskinesia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Hunter | Baylor College of Medicine | 713-798-6556 | chunter@bcm.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
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| carbidopa-levodopa (Sinemet) |
| Drug |
at subjects current stable dose |
|
carbidopa-levodopa at subjects current stable dose
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | A-Carbidopa/Levodopa Arm | carbidopa-levodopa at subjects current stable dose | 0 | 20 | 0 | 20 | 2 | 20 |
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |