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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014