Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00228150
First received: September 26, 2005
Last updated: December 22, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Drug: SR57667B
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Time to disability warranting introduction of Ldopaor a dopamine agonist.

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

Enrollment: 564
Study Start Date: July 2003
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228150

Locations
Austria
Sanofi-Aventis Administrative Office
Wien, Austria
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Denmark
Sanofi-Aventis Administrative Office
Horsholm, Denmark
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Morocco
Sanofi-Aventis Administrative Office
Casablanca, Morocco
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Tunisia
Sanofi-Aventis Administrative Office
Megrine, Tunisia
United Kingdom
Sanofi-Aventis Administrative Office
Guilford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Chair: Mark GUTMAN, MD Scientific Advisory Committee
Study Chair: Werner POEWE, MD Scientific Advisory Committee
Study Chair: Olivier RASCOL, MD Scientific Advisory Committee
Study Chair: Eduardo TOLOSA, MD Scientific Advisory Committee
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00228150     History of Changes
Other Study ID Numbers: EFC5287
Study First Received: September 26, 2005
Last Updated: December 22, 2008
Health Authority: Spain: Spanish Agency of Medicines
Netherlands: Medicines Evaluation Board (MEB)
Sweden: Medical Products Agency

Keywords provided by Sanofi:
Parkinson Disease
levodopa
dopamine agonists

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

ClinicalTrials.gov processed this record on April 15, 2014