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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00407212

Enrollment

301

Registered

2006-12-04

Start date

2002-01-31

Completion date

2003-11-30

Last updated

2011-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

early stage idiopathic Parkinson's disease

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

Interventions

DRUGTCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026