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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00228150

Collaborator

(none)

564

Enrollment

Locations

Duration (Months)

43.4

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: SR57667B	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

564 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Time to disability warranting introduction of Ldopaor a dopamine agonist. []

Secondary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Sanofi-Aventis Administrative Office	Wien	Austria
2	Sanofi-Aventis Administrative Office	Laval	Canada
3	Sanofi-Aventis Administrative Office	Horsholm	Denmark
4	Sanofi-Aventis Administrative Office	Paris	France
5	Sanofi-Aventis Administrative Office	Berlin	Germany
6	Sanofi-Aventis Administrative Office	Casablanca	Morocco
7	Sanofi-Aventis Administrative Office	Gouda	Netherlands
8	Sanofi-Aventis Administrative Office	Porto Salvo	Portugal
9	Sanofi-Aventis Administrative Office	Midrand	South Africa
10	Sanofi-Aventis Administrative Office	Barcelona	Spain
11	Sanofi-Aventis Administrative Office	Bromma	Sweden
12	Sanofi-Aventis Administrative Office	Megrine	Tunisia
13	Sanofi-Aventis Administrative Office	Guilford Surrey	United Kingdom