Status:
COMPLETED
Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease
Lead Sponsor:
Sanofi
Conditions:
Parkinson Disease
Eligibility:
All Genders
35+ years
Phase:
PHASE2
Brief Summary
The primary objective is to assess the effect of SR57667B at the dose of 4 mg/d on the progression of Parkinson symptoms in patients with early PD. The primary outcome will be the time to progression ...
Detailed Description
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.
Eligibility Criteria
Inclusion
- 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.
- Untreated patients.
- Generally healthy and ambulatory.
- Patient has given his informed written consent and is capable of following study procedures.
Exclusion
- Any indication of forms of parkinsonism other than PD.
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
564 Patients enrolled
Trial Details
Trial ID
NCT00228150
Start Date
July 1 2003
End Date
April 1 2006
Last Update
December 23 2008
Active Locations (13)
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1
Sanofi-Aventis Administrative Office
Vienna, Austria
2
Sanofi-Aventis Administrative Office
Laval, Canada
3
Sanofi-Aventis Administrative Office
Hørsholm, Denmark
4
Sanofi-Aventis Administrative Office
Paris, France