Status:
COMPLETED
An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects
Lead Sponsor:
XenoPort, Inc.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation \[administered with Lodosyn® (carbidopa)\] and Sinemet® tablets in sub...
Detailed Description
This is a Phase 1/Phase 2 multiple-dose, multi-center, open-label, two period sequential-treatment study in subjects with Parkinson's disease to assess the pharmacokinetics, pharmacodynamics, and safe...
Eligibility Criteria
Inclusion
- Subjects with a clinical diagnosis of idiopathic Parkinson's disease, confirmed by the presence of at least two cardinal signs of the disease (resting tremor, bradykinesia, rigidity).
- Subjects must have predictable motor fluctuations of the wearing off type, defined by wearing off in at least 50% of inter-dose intervals between the first and the last daily doses as recorded on the on/off diary over 3 days (Days -4 to -2) in the Screening Period.
- Subjects must be on stable TID or QID Sinemet® or carbidopa/levodopa regimens from morning through early evening, with a total daily dose ranging from 400 mg to 1000 mg of levodopa, for at least 1 week prior to Screening.
Exclusion
- History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
- Subject has greater than or equal to moderately disabling dyskinesias for greater than 25% of the waking day as assessed by a score of 2 or more on item 32 and a score of 2 or more on item 33 on the UPDRS at Screening.
- Subjects who are dosing with Sinemet® or carbidopa/levodopa during the night time.
- Subjects who have significant neurological symptoms not accounted for by Parkinson's disease.
- Subjects who are taking concomitantly COMT inhibitors (i.e., entacapone or tolcapone) or treated with Stalevo®, Sinemet® CR, or Madopar®/Prolopa® (levodopa/benserazide).
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00914602
Start Date
May 1 2009
End Date
January 1 2010
Last Update
May 5 2021
Active Locations (2)
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1
XenoPort Investigational Site
Peoria, Arizona, United States, 85381
2
XenoPort Investigational Site
Bingham Farms, Michigan, United States, 48025