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

A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Outpatients With Early Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: SR57667B

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 564
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria
    • Sanofi-Aventis Administrative Office
• Canada
  • Laval, Canada
    • Sanofi-Aventis Administrative Office
• Denmark
  • Horsholm, Denmark
    • Sanofi-Aventis Administrative Office
• France
  • Paris, France
    • Sanofi-Aventis Administrative Office
• Germany
  • Berlin, Germany
    • Sanofi-Aventis Administrative Office
• Morocco
  • Casablanca, Morocco
    • Sanofi-Aventis Administrative Office
• Netherlands
  • Gouda, Netherlands
    • Sanofi-Aventis Administrative Office
• Portugal
  • Porto Salvo, Portugal
    • Sanofi-Aventis Administrative Office
• South Africa
  • Midrand, South Africa
    • Sanofi-Aventis Administrative Office
• Spain
  • Barcelona, Spain
    • Sanofi-Aventis Administrative Office
• Sweden
  • Bromma, Sweden
    • Sanofi-Aventis Administrative Office
• Tunisia
  • Megrine, Tunisia
    • Sanofi-Aventis Administrative Office
• United Kingdom
  • Guilford Surrey, United Kingdom
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to disability warranting introduction of Ldopaor a dopamine agonist.

Secondary Outcome Measures

Outcome Measure
Unified Parkinson's Disease Rating Scale (UPDRS)

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: September 26, 2005
• First Submitted That Met QC Criteria: September 26, 2005
• First Posted (Estimate): September 28, 2005

Study Record Updates

• Last Update Posted (Estimate): December 23, 2008
• Last Update Submitted That Met QC Criteria: December 22, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: levodopa; Parkinson Disease; dopamine agonists
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: EFC5287