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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.
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR57667B | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disability warranting introduction of Ldopaor a dopamine agonist. |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark GUTMAN, MD | Scientific Advisory Committee | Study Chair |
| Werner POEWE, MD | Scientific Advisory Committee | Study Chair |
| Olivier RASCOL, MD | Scientific Advisory Committee | Study Chair |
| Eduardo TOLOSA, MD | Scientific Advisory Committee | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Vienna | Austria | ||||
| Sanofi-Aventis Administrative Office |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Laval |
| Canada |
| Sanofi-Aventis Administrative Office | Hørsholm | Denmark |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Casablanca | Morocco |
| Sanofi-Aventis Administrative Office | Gouda | Netherlands |
| Sanofi-Aventis Administrative Office | Porto Salvo | Portugal |
| Sanofi-Aventis Administrative Office | Midrand | South Africa |
| Sanofi-Aventis Administrative Office | Barcelona | Spain |
| Sanofi-Aventis Administrative Office | Bromma | Sweden |
| Sanofi-Aventis Administrative Office | Mégrine | Tunisia |
| Sanofi-Aventis Administrative Office | Guilford Surrey | United Kingdom |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |