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

Novartis

Status and phase

Completed

Phase 2

Phase 1

Conditions

Parkinson's Disease

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

TCH346B103

Details and patient eligibility

About

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

Full description

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

Enrollment

301 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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