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Study of the Effect of SR57667B on the Progression of Symptoms 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, levodopa, dopamine agonists

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. Untreated patients. 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 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.

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
  • 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

Time to disability warranting introduction of Ldopaor a dopamine agonist.

Secondary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS)

Full Information

First Posted
September 26, 2005
Last Updated
December 22, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00228150
Brief Title
Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease
Official Title
A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B 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
July 2003 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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 of disability warranting initiation of L-dopa or a dopamine agonist. Secondary outcomes will comprise assessments of symptoms, activities of daily living and global clinical status.
Detailed Description
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, levodopa, dopamine agonists

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SR57667B
Primary Outcome Measure Information:
Title
Time to disability warranting introduction of Ldopaor a dopamine agonist.
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. Untreated patients. 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark GUTMAN, MD
Organizational Affiliation
Scientific Advisory Committee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Werner POEWE, MD
Organizational Affiliation
Scientific Advisory Committee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Olivier RASCOL, MD
Organizational Affiliation
Scientific Advisory Committee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eduardo TOLOSA, MD
Organizational Affiliation
Scientific Advisory Committee
Official's Role
Study Chair
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Wien
Country
Austria
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Horsholm
Country
Denmark
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Casablanca
Country
Morocco
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Porto Salvo
Country
Portugal
Facility Name
Sanofi-Aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Bromma
Country
Sweden
Facility Name
Sanofi-Aventis Administrative Office
City
Megrine
Country
Tunisia
Facility Name
Sanofi-Aventis Administrative Office
City
Guilford 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 the Progression of Symptoms in Patients With Parkinson's Disease

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