Clinical trial NCT00228150: Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson Disease
levodopa
dopamine agonists
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-28
Enrollment: 564
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Time to disability warranting introduction of Ldopaor a dopamine agonist.
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Horsholm
country: Denmark
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Casablanca
country: Morocco
facility: Sanofi-Aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
city: Porto Salvo
country: Portugal
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
city: Megrine
country: Tunisia
facility: Sanofi-Aventis Administrative Office
city: Guilford Surrey
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Scientific Advisory Committee
name: Mark GUTMAN, MD
role: STUDY_CHAIR
affiliation: Scientific Advisory Committee
name: Werner POEWE, MD
role: STUDY_CHAIR
affiliation: Scientific Advisory Committee
name: Olivier RASCOL, MD
role: STUDY_CHAIR
affiliation: Scientific Advisory Committee
name: Eduardo TOLOSA, MD
role: STUDY_CHAIR
References: