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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SR57667B
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, 5-fluorodopa

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Outcomes

Primary Outcome Measures

Change in average (left and right) putamen 18F-Dopa influx constant (Ki) from baseline to two year 18F-Dopa PET

Secondary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS)

Full Information

First Posted
September 16, 2005
Last Updated
December 22, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00220272
Brief Title
Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, 5-fluorodopa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SR57667B
Primary Outcome Measure Information:
Title
Change in average (left and right) putamen 18F-Dopa influx constant (Ki) from baseline to two year 18F-Dopa PET
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Remy, MD
Organizational Affiliation
Service Hospitalier Frédéric Joliot, CEA, Orsay France
Official's Role
Study Chair
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Helsinki
Country
Finland
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Geneva
Country
Switzerland
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford Surrey
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.sanofi-aventis.com
Description
Related Info

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

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