Status:
COMPLETED
A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects
Lead Sponsor:
XenoPort, Inc.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief Summary
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/Ca...
Eligibility Criteria
Inclusion
- 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.
- 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
- History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
- Subject has moderately or severely disabling dyskinesias for greater than 25% of the waking day
- Subjects who have significant neurological symptoms not accounted for by Parkinson's disease
- Subjects who are taking Sinemet® CR, Parcopa®, concomitant COMT inhibitors (i.e., entacapone or tolcapone), Stalevo®, or benserazide containing levodopa preparations Madopar® or Prolopa®.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01171313
Start Date
July 1 2010
End Date
December 1 2011
Last Update
February 18 2021
Active Locations (12)
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1
XenoPort Clinical Site
Phoenix, Arizona, United States, 85013
2
XenoPort Clinical Site
Little Rock, Arkansas, United States, 72205
3
XenoPort Clinical Site
Long Beach, California, United States, 90806
4
XenoPort Clinical Site
Sunnyvale, California, United States, 94085