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This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the need for symptomatic treatment with dopaminergic agents", defined as the number of days from the first dose of TCH346 study treatment to the date when it symptomatic treatment is required as determined by the investigator | ||
| Safety assessments as based on the frequency of adverse events and the number of laboratory values that fall outside of the ranges. |
| Measure | Description | Time Frame |
|---|---|---|
| Annual change rates for Unified Parkinsons Disease Rating Scalescore | ||
| Changes in UPDRS score after 4 weeks and after withdrawal of study treatment | ||
| Percentage of patients needing symptomatic treatment within 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Additional inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
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| Berkley |
| California |
| United States |
| Fountain Valley | California | United States |
| Sunnyvale | California | United States |
| New Haven | Connecticut | United States |
| Chicago | Illinois | United States |
| Southfield | Michigan | United States |
| Great Falls | Montana | United States |
| Columbus | Ohio | United States |
| Pawtucket | Rhode Island | United States |
| Houston | Texas | United States |
| Novartis Investigative Site | Belo Horizonte | Brazil |
| Novartis Investigative Site | Curitiba | Brazil |
| Novartis Investigative Site | Fortaleza | Brazil |
| Novartis Investigative Site | São Paulo | Brazil |
| Novartis Investigative Site | Caligary | Canada |
| Novartis Investigative Site | Hallifax | Canada |
| Novartis Investigative Site | Markham | Canada |
| Novartis Investigative Site | Montreal | Canada |
| Novartis Investigative Site | Vancouver | Canada |
| Novartis Investigative Site | Winnipeg | Canada |
| Novartis Investigative Site | Clermont | France |
| Marseille | France |
| Novartis Investigative Site | Paris | France |
| Saint-Herblain | France |
| Tours | France |
| Berlin | Germany |
| Bochum | Germany |
| Leipzig | Germany |
| Wiesbaden | Germany |
| Genova | Italy |
| Lido di Camaiore | Italy |
| Maples | Italy |
| Milan | Italy |
| Pescara | Italy |
| 's-Hertogenbosch | Netherlands |
| Amsterdam | Netherlands |
| Bedra | Netherlands |
| Biaricum | Netherlands |
| Dordrecht | Netherlands |
| Groningen | Netherlands |
| Lisbon | Portugal |
| Birmingham | United Kingdom |
| Cambridge | United Kingdom |
| Sheffield | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C111178 | dibenzo(b,f)oxepin-10-ylmethyl-methyl-prop-2-ynyl-amine |
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