View Clinical Trial (Medical Research Study)

An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects - NCT00914602-85381(Clinical Trial 296717)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Peoria
State:  
AZ
Zip Code: 85381
Conditions: Parkinson's Disease
Purpose: 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.
Study summary:
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).
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: February 17, 2010
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.