Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease
NCT ID: NCT00228150
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
564 participants
INTERVENTIONAL
2003-07-31
2006-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SR57667B
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
* Untreated patients.
* 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 L-Dopa, dopamine agonist, 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
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
sanofi-aventis
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark GUTMAN, MD
Role: STUDY_CHAIR
Scientific Advisory Committee
Werner POEWE, MD
Role: STUDY_CHAIR
Scientific Advisory Committee
Olivier RASCOL, MD
Role: STUDY_CHAIR
Scientific Advisory Committee
Eduardo TOLOSA, MD
Role: STUDY_CHAIR
Scientific Advisory Committee
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sanofi-Aventis Administrative Office
Vienna, , Austria
Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
Hørsholm, , Denmark
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Casablanca, , Morocco
Sanofi-Aventis Administrative Office
Gouda, , Netherlands
Sanofi-Aventis Administrative Office
Porto Salvo, , Portugal
Sanofi-Aventis Administrative Office
Midrand, , South Africa
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Bromma, , Sweden
Sanofi-Aventis Administrative Office
Mégrine, , Tunisia
Sanofi-Aventis Administrative Office
Guilford Surrey, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EFC5287
Identifier Type: -
Identifier Source: org_study_id