An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects
Information source: XenoPort, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: XP21279 (Drug); Sinemet® (Drug); Lodosyn® (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: XenoPort, Inc.
Summary
The purpose of the study is to assess the pharmacokinetics (PK), pharmacodynamics, and
safety of XP21279 sustained release (SR3) formulation [administered with Lodosyn®
(carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease with Motor
Fluctuations.
Clinical Details
Official title: An Exploratory Pharmacokinetic, Pharmacodynamic and Safety Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetic parameters
Secondary outcome: Pharmacodynamic parameters
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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).
2. 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.
3. 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 Criteria:
1. History, signs, or symptoms suggesting the diagnosis of secondary or atypical
Parkinsonism.
2. 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.
3. Subjects who are dosing with Sinemet® or carbidopa/levodopa during the night time.
4. Subjects who have significant neurological symptoms not accounted for by Parkinson's
disease.
5. Subjects who are taking concomitantly COMT inhibitors (i. e., entacapone or tolcapone)
or treated with Stalevo®, Sinemet® CR, or Madopar®/Prolopa® (levodopa/benserazide).
Locations and Contacts
XenoPort Investigational Site, Peoria, Arizona 85381, United States
XenoPort Investigational Site, Bingham Farms, Michigan 48025, United States
Additional Information
Starting date: May 2009
Last updated: May 18, 2011
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