A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
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:
- 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 Criteria:
- 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®.
Sites / Locations
- XenoPort Clinical Site
- XenoPort Clinical Site
- XenoPort Clinical Site
- XenoPort Clinical Site
- XenoPort Clinical Site
- XenoPort Clinical Site
- XenoPort Clinical Site
- XenoPort Clinical Site
- XenoPort Clinical Site
- XenoPort Clinical Site
- XenoPort Clinical Site
- XenoPort Clinical Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Treatment sequence 1
Treatment sequence 2
Treatment sequence 3
Treatment sequence 4
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.