Loading clinical trials...

A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT00407212•Novartis

View on ClinicalTrials.gov

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

Age

30 - 80 years

Sex

ALL

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

Locations (45)

Phoenix, Arizona, United States

Berkley, California, United States

Fountain Valley, California, United States

Sunnyvale, California, United States

New Haven, Connecticut, United States

Chicago, Illinois, United States

Southfield, Michigan, United States

Great Falls, Montana, United States

Columbus, Ohio, United States

Pawtucket, Rhode Island, United States

Key Dates

Start Date

January 1, 2002

Primary Completion Date

November 1, 2003

Completion Date

November 1, 2003

Last Updated

November 23, 2011

Enrollment

301

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

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

DRUG

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGNA

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

View study

RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 23, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations