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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Parkinson Disease

Treatments

Drug: SR57667B

Study type

Interventional

Funder types

Industry

Identifiers

NCT00228150

EFC5287

Details and patient eligibility

About

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.

Full description

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

Enrollment

564 patients

Sex

All

Ages

35+ years old

Volunteers

No 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.