A Efficacy, Safety and Pharmacokinetic Study of XP21279 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 and carbidopa (experimental) (Drug); Sinemet (comparator) (Drug); Placebo for XP21279 and carbidopa (Drug); Placebo for Sinemet (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: XenoPort, Inc. Official(s) and/or principal investigator(s): Dan Chen, M.D., Study Director, Affiliation: XenoPort, Inc.
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/Carbidopa and Sinemet and to explore exposure-response
relationships in a subset of subjects.
Clinical Details
Official title: A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.
Secondary outcome: Proportion of responders ("much improved" or "very much improved") on Investigator-rated and patient-rated CGI-I at end of double-blind Maintenance Treatment periods
Eligibility
Minimum age: 30 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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.
2. 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:
1. History, signs, or symptoms suggesting the diagnosis of secondary or atypical
Parkinsonism.
2. Subject has moderately or severely disabling dyskinesias for greater than 25% of the
waking day
3. Subjects who have significant neurological symptoms not accounted for by Parkinson's
disease
4. Subjects who are taking Sinemet® CR, Parcopa®, concomitant COMT inhibitors (i. e.,
entacapone or tolcapone), Stalevo®, or benserazide containing levodopa preparations
Madopar® or Prolopa®.
Locations and Contacts
XenoPort Clinical Site, Phoenix, Arizona 85013, United States
XenoPort Clinical Site, Little Rock, Arkansas 72205, United States
XenoPort Clinical Site, Long Beach, California 90806, United States
XenoPort Clinical Site, Sunnyvale, California 94085, United States
XenoPort Clinical Site, Naples, Florida 34102, United States
XenoPort Clinical Site, Tampa, Florida 33606, United States
XenoPort Clinical Site, Kansas City, Kansas 66160, United States
XenoPort Clinical Site, Bingham Farms, Michigan 48025, United States
XenoPort Clinical Site, West Bloomfield, Michigan 48322-3013, United States
XenoPort Clinical Site, New Brunswick, New Jersey 08901, United States
XenoPort Clinical Site, Tulsa, Oklahoma 74137, United States
XenoPort Clinical Site, Houston, Texas 77030, United States
Additional Information
Starting date: July 2010
Last updated: February 4, 2013
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