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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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.