A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT01171313

Run by

XenoPort, Inc.

People needed

35

Starts

2010-07-01

Expected to finish

2011-12-01

Last updated by the study team

2021-02-18

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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®.

Where it is running

• XenoPort Clinical Site — Phoenix, Arizona, United States
• XenoPort Clinical Site — Little Rock, Arkansas, United States
• XenoPort Clinical Site — Long Beach, California, United States
• XenoPort Clinical Site — Sunnyvale, California, United States
• XenoPort Clinical Site — Naples, Florida, United States
• XenoPort Clinical Site — Tampa, Florida, United States
• XenoPort Clinical Site — Kansas City, Kansas, United States
• XenoPort Clinical Site — Bingham Farms, Michigan, United States
• XenoPort Clinical Site — West Bloomfield, Michigan, United States
• XenoPort Clinical Site — New Brunswick, New Jersey, United States
• XenoPort Clinical Site — Tulsa, Oklahoma, United States
• XenoPort Clinical Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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