Parkinson Disease
Conditions
Keywords
Parkinson Disease, levodopa, dopamine agonists
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.
Interventions
DRUGSR57667B
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to disability warranting introduction of Ldopaor a dopamine agonist. | — |
Secondary
| Measure | Time frame |
|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) | — |
Countries
Austria, Canada, Denmark, France, Germany, Morocco, Netherlands, Portugal, South Africa, Spain, Sweden, Tunisia, United Kingdom
Outcome results
None listed