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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00407212
First received: November 30, 2006
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Parkinson's Disease
 Drug: TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Enrollment: 301
Study Start Date: January 2002
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407212

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States
United States, California
Berkley, California, United States
Fountain Valley, California, United States
Sunnyvale, California, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Illinois
Chicago, Illinois, United States
United States, Michigan
Southfield, Michigan, United States
United States, Montana
Great Falls, Montana, United States
United States, Ohio
Columbus, Ohio, United States
United States, Rhode Island
Pawtucket, Rhode Island, United States
United States, Texas
Houston, Texas, United States
Brazil
Novartis Investigative Site
Belo Horizonte, Brazil
Novartis Investigative Site
Curitiba, Brazil
Novartis Investigative Site
Fortaleza, Brazil
Novartis Investigative Site
Sao Paolo, Brazil
Canada
Novartis Investigative Site
Caligary, Canada
Novartis Investigative Site
Hallifax, Canada
Novartis Investigative Site
Markham, Canada
Novartis Investigative Site
Montreal, Canada
Novartis Investigative Site
Vancouver, Canada
Novartis Investigative Site
Winnipeg, Canada
France
Novartis Investigative Site
Clermont, France
Marseille, France
Novartis Investigative Site
Paris, France
St. Herblain, France
Tours, France
Germany
Berlin, Germany
Bochum, Germany
Leipzig, Germany
Wiesbaden, Germany
Italy
Genova, Italy
Lido di Camaiore, Italy
Maples, Italy
Milan, Italy
Pescara, Italy
Netherlands
Amsterdam, Netherlands
Bedra, Netherlands
Biaricum, Netherlands
Den Bosch, Netherlands
Dordrecht, Netherlands
Groningen, Netherlands
Portugal
Lisboa, Portugal
United Kingdom
Birmingham, United Kingdom
Cambridge, United Kingdom
Sheffield, United Kingdom
Sponsors and Collaborators
Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00407212     History of Changes
Other Study ID Numbers: TCH346B103
Study First Received: November 30, 2006
Last Updated: November 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
early stage idiopathic Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Movement Disorders
Neurodegenerative Diseases
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013