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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

Page last updated: August 23, 2015

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