A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy

Phase 1

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT00407212
• Lead Sponsor: Novartis

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2003-11
• Study Completion: 2003-11
• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-11-30
• Study First Posted: 2006-12-04
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-22
• Last Update Posted: 2011-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇫🇷 Paris, France