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Completed

NCT Number: NCT00407212

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

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Novartis Investigative Site, Belo Horizonte, Brazil

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About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  1. 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

  2. Safety assessments as based on the frequency of adverse events and the number of laboratory values that fall outside of the ranges.

Secondary outcomes

  1. Annual change rates for Unified Parkinsons Disease Rating Scalescore

  2. Changes in UPDRS score after 4 weeks and after withdrawal of study treatment

  3. Percentage of patients needing symptomatic treatment within 12 months

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Dec 4, 2006
Registry last updated
Nov 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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