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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228150
• Other study ID #: EFC5287
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2005
• Last updated: December 22, 2008
• Start date: July 2003
• Est. completion date: April 2006

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesNetherlands: Medicines Evaluation Board (MEB)Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• SR57667B

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Austria,  Canada,  Denmark,  France,  Germany,  Morocco,  Netherlands,  Portugal,  South Africa,  Spain,  Sweden,  Tunisia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disability warranting introduction of Ldopaor a dopamine agonist.
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS)

External Links

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