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

Phase 2

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT00228150
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-09-26
• Study First Submitted QC: 2005-09-26
• Study First Posted: 2005-09-28
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-22
• Last Update Posted: 2008-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 564

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to disability warranting introduction of Ldopaor a dopamine agonist.

Secondary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (UPDRS)

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇬🇧 Guilford Surrey, United Kingdom