Status:
COMPLETED
A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy
Lead Sponsor:
Novartis
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
Detailed Description
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
Eligibility Criteria
Inclusion
- Male or female ,aged 30-80 years
- 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
- A history of alcohol or drug abuse in the past year
- 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
- Additional inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2003
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00407212
Start Date
January 1 2002
End Date
November 1 2003
Last Update
November 23 2011
Active Locations (45)
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1
Phoenix, Arizona, United States
2
Berkley, California, United States
3
Fountain Valley, California, United States
4
Sunnyvale, California, United States