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

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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

NCT00407212
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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

45

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Data sourced from clinicaltrials.gov

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