Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220272
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 23, 2008
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Brief Summary:
  • 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: SR57667B Phase 2

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  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in average (left and right) putamen 18F-Dopa influx constant (Ki) from baseline to two year 18F-Dopa PET

Secondary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale (UPDRS)

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00220272

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
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Study Chair: Philippe Remy, MD Service Hospitalier Frédéric Joliot, CEA, Orsay France

Additional Information:
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00220272     History of Changes
Other Study ID Numbers: ACT5288
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 23, 2008
Last Verified: December 2008

Keywords provided by Sanofi:
Parkinson Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases