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

Parkinson's Disease Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407212
• Other study ID #: TCH346B103
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 30, 2006
• Last updated: November 22, 2011
• Start date: January 2002
• Est. completion date: November 2003

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents

Description:

This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)

Locations

Country	Name	City	State
Brazil	Novartis Investigative Site	Belo Horizonte
Brazil	Novartis Investigative Site	Curitiba
Brazil	Novartis Investigative Site	Fortaleza
Brazil	Novartis Investigative Site	Sao Paolo
Canada	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
France	Novartis Investigative Site	Clermont
France	Novartis Investigative Site	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  France,  Germany,  Italy,  Netherlands,  Portugal,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Safety assessments as based on the frequency of adverse events and the number of laboratory values that fall outside of the ranges.
Secondary	Annual change rates for Unified Parkinsons Disease Rating Scalescore
Secondary	Changes in UPDRS score after 4 weeks and after withdrawal of study treatment
Secondary	Percentage of patients needing symptomatic treatment within 12 months