Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's Disease
NCT ID: NCT00220272
Last Updated: 2008-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2004-01-31
2007-03-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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SR57667B
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Philippe Remy, MD
Role: STUDY_CHAIR
Service Hospitalier Frédéric Joliot, CEA, Orsay France
Locations
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Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
Helsinki, , Finland
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Gouda, , Netherlands
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Geneva, , Switzerland
Sanofi-Aventis Administrative Office
Guildford Surrey, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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ACT5288
Identifier Type: -
Identifier Source: org_study_id