A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy
NCT ID: NCT00407212
Last Updated: 2011-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
301 participants
INTERVENTIONAL
2002-01-31
2003-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of early stage idiopathic Parkinson's disease
* Experiencing two of the three following signs; bradykinesia, rigidity, and tremor
* Not currently taking any antiparkinson medication
Exclusion Criteria
* A diagnosis psychiatric illness
* Patients who currently are taking MAO inhibitors within 30 days of entering the study
* Patients who are hypersensitive to selegiline, MAO-B inhibitors, or tricyclic antidepressants
30 Years
80 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
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
Countries
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Other Identifiers
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TCH346B103
Identifier Type: -
Identifier Source: org_study_id