Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

A Phase II, Randomized, Multicenter, Multinational, Double-Blind, Placebo-Controlled, Study of the Effect of SR57667B on Dopaminergic Nigro-Striatal Function Assessed by 18F-Dopa PET Imaging in Outpatients With Early Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220272
• Other study ID #: ACT5288
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: December 22, 2008
• Start date: January 2004
• Est. completion date: March 2007

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Canada: Health CanadaNetherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial Summary

• The primary objective is to study the effect of SR57667B at the dose of 4 mg/d on progression of dopaminergic nigro-striatal lesions assessed by 18F-Dopa PET imaging.

• Secondary objectives are to assess the effect of SR57667B on symptomatic decline in patients with early PD, to assess the safety/tolerability of SR57667B in patients with early PD and to document plasma concentrations of SR57667 in patients with early PD.

Description:

Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.Randomization stratified on the dopaminergic treatment, in two strata: treatment by levodopa or dopamine agonist.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• 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.

• Patient optimized on monotherapy by levodopa or a dopamine agonist·

• 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 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
Canada	Sanofi-Aventis Administrative Office	Laval
Finland	Sanofi-Aventis Administrative Office	Helsinki
France	Sanofi-Aventis Administrative Office	Paris
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Spain	Sanofi-Aventis Administrative Office	Barcelona
Switzerland	Sanofi-Aventis Administrative Office	Geneva
United Kingdom	Sanofi-Aventis Administrative Office	Guildford Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Canada,  Finland,  France,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average (left and right) putamen 18F-Dopa influx constant (Ki) from baseline to two year 18F-Dopa PET
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS)

External Links

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