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A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects - NCT01171313-48025(Clinical Trial 712832)



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City:  Bingham Farms
State:  
MI
Zip Code: 48025
Conditions: Parkinson's Disease
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: 1. 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: - Wearing-off in at least half (50%) of inter-dose intervals between the first and the last daily doses averaged over the 3 diary days, and - An average daily "off" time of 2 hours after the first "on" of the day through awake time up to midnight. 2. Subjects must be on one of the following stable QID 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: 1. History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism. 2. Subject has moderately or severely disabling dyskinesias for greater than 25% of the waking day 3. Subjects who have significant neurological symptoms not accounted for by Parkinson's disease 4. Subjects who are taking Sinemet® CR, Parcopa®, concomitant COMT inhibitors (i.e., entacapone or tolcapone), Stalevo®, or benserazide containing levodopa preparations Madopar® or Prolopa®.
Study is available at: XenoPort Clinical Site
Bingham Farms, MI 48025
United States

Primary Contact:
Study Manager
Phone: 408-616-7129

Secondary Contact:
XenoPort Study Manager
Email: KMcGuire@xenoport.com
Phone: (408) 616-7129
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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