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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

Page last updated: August 23, 2015

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