An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects
Completed · Phase 1/Phase 2
Conditions studied: Parkinson's Disease
In brief
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 subjects with Parkinson's disease with Motor Fluctuations.
Key facts
- Study ID
- NCT00914602
- Run by
- XenoPort, Inc.
- People needed
- 14
- Starts
- 2009-05-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2021-05-05
Who can join
Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- XenoPort Investigational Site — Peoria, Arizona, United States
- XenoPort Investigational Site — Bingham Farms, Michigan, United States
Full record on ClinicalTrials.gov
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