Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's Disease
December 22, 2008 updated by: Sanofi
A Phase II, Randomized, Multicenter, Multinational, Double-Blind, Placebo-Controlled, Study of the Effect of SR57667B on Dopaminergic Nigro-Striatal Function Assessed by 18F-Dopa PET Imaging in Outpatients With Early Parkinson's Disease
- The primary objective is to study the effect of SR57667B at the dose of 4 mg/d on progression of dopaminergic nigro-striatal lesions assessed by 18F-Dopa PET imaging.
- Secondary objectives are to assess the effect of SR57667B on symptomatic decline in patients with early PD, to assess the safety/tolerability of SR57667B in patients with early PD and to document plasma concentrations of SR57667 in patients with early PD.
Study Overview
Detailed Description
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.Randomization stratified on the dopaminergic treatment, in two strata: treatment by levodopa or dopamine agonist.
Study Type
Interventional
Enrollment (Actual)
183
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Laval, Canada
- Sanofi-Aventis Administrative Office
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Helsinki, Finland
- Sanofi-Aventis Administrative Office
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Paris, France
- Sanofi-Aventis Administrative Office
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Gouda, Netherlands
- Sanofi-Aventis Administrative Office
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Barcelona, Spain
- Sanofi-Aventis Administrative Office
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Geneva, Switzerland
- Sanofi-Aventis Administrative Office
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Guildford Surrey, United Kingdom
- Sanofi-Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female outpatients.
- Age >=35 years at screening.
- Diagnosis of Parkinson's syndrome, on at least two of the three key Parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity.
- Duration of the disease of less than 3 years since diagnosis.
- Modified Hoehn and Yahr stage <= 2.5.
- Patient optimized on monotherapy by levodopa or a dopamine agonist·
- Generally healthy and ambulatory.
- Patient has given his informed written consent and is capable of following study procedures.
Exclusion Criteria:
- Any indication of forms of parkinsonism other than PD.
- Severe resting tremor. Presence of either dyskinesia, fluctuations, or loss of postural reflexes·
- Treatment with amantadine, anticholinergics, catechol-o-methyltransferase (COMT ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa. Electroconvulsive therapy (ECT).Use of CYP3A4 strong, and moderate inducers or inhibitors. Participation in another clinical trial with an investigational drug within two months prior to randomization.
- Dementia, uncontrolled depression, psychotic disorder. History of substance-related disorders including alcohol or other substance use disorders.
- Females of child bearing potential.
- Evidence (detected by history, physical examination and/or laboratory/ECG tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. Alterations of laboratory tests or ECG findings of potential clinical significance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change in average (left and right) putamen 18F-Dopa influx constant (Ki) from baseline to two year 18F-Dopa PET
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Secondary Outcome Measures
Outcome Measure |
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Unified Parkinson's Disease Rating Scale (UPDRS)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Philippe Remy, MD, Service Hospitalier Frédéric Joliot, CEA, Orsay France
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (ACTUAL)
March 1, 2007
Study Completion (ACTUAL)
March 1, 2007
Study Registration Dates
First Submitted
September 16, 2005
First Submitted That Met QC Criteria
September 16, 2005
First Posted (ESTIMATE)
September 22, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
December 23, 2008
Last Update Submitted That Met QC Criteria
December 22, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACT5288
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.