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| ID | Type | Description | Link |
|---|---|---|---|
| XenoPort | Other Identifier | XenoPort |
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The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after administration of XP21279/Carbidopa and Sinemet and to explore exposure-response relationships in a subset of subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1 | Experimental | Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence. |
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| Treatment sequence 2 | Experimental | Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence. |
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| Treatment sequence 3 | Experimental | Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence. |
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| Treatment sequence 4 | Experimental | Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XP21279 and carbidopa (experimental) | Drug | Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders ("much improved" or "very much improved") on Investigator-rated and patient-rated CGI-I at end of double-blind Maintenance Treatment periods | 2 weeks |
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Inclusion Criteria:
Subjects must have predictable motor fluctuations of the wearing off type, defined by meeting the following criteria based on the on/off diaries recorded over 3 days in the Screening Period:
Subjects must be on one of the following stable QID or 5 times daily regimens for at least 4 weeks prior to Screening: Sinemet® or carbidopa-levodopa, with a total daily dose ranging from 400 mg to 1000 mg of levodopa
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Chen, M.D. | XenoPort, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| XenoPort Clinical Site | Phoenix | Arizona | 85013 | United States | ||
| XenoPort Clinical Site |
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| Sinemet (comparator) | Drug | Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet. |
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| Placebo for XP21279 and carbidopa | Drug | Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa |
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| Placebo for Sinemet | Drug | Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet |
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| Little Rock |
| Arkansas |
| 72205 |
| United States |
| XenoPort Clinical Site | Long Beach | California | 90806 | United States |
| XenoPort Clinical Site | Sunnyvale | California | 94085 | United States |
| XenoPort Clinical Site | Naples | Florida | 34102 | United States |
| XenoPort Clinical Site | Tampa | Florida | 33606 | United States |
| XenoPort Clinical Site | Kansas City | Kansas | 66160 | United States |
| XenoPort Clinical Site | Bingham Farms | Michigan | 48025 | United States |
| XenoPort Clinical Site | West Bloomfield | Michigan | 48322-3013 | United States |
| XenoPort Clinical Site | New Brunswick | New Jersey | 08901 | United States |
| XenoPort Clinical Site | Tulsa | Oklahoma | 74137 | United States |
| XenoPort Clinical Site | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D002230 | Carbidopa |
| C009265 | carbidopa, levodopa drug combination |
| ID | Term |
|---|---|
| D008750 | Methyldopa |
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006834 | Hydrazines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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