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

November 22, 2011 updated by: Novartis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Belo Horizonte, Brazil
        • Novartis Investigative Site
      • Curitiba, Brazil
        • Novartis Investigative Site
      • Fortaleza, Brazil
        • Novartis Investigative Site
      • Sao Paolo, Brazil
        • Novartis Investigative Site
  • Canada
      • 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
        • Novartis Investigative Site
  • France
      • Clermont, France
        • Novartis Investigative Site
      • Marseille, France
      • Paris, France
        • Novartis Investigative Site
      • 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
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Berkley, California, United States
      • Fountain Valley, California, United States
      • Sunnyvale, California, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Illinois
      • Chicago, Illinois, United States
    • Michigan
      • Southfield, Michigan, United States
    • Montana
      • Great Falls, Montana, United States
    • Ohio
      • Columbus, Ohio, United States
    • Rhode Island
      • Pawtucket, Rhode Island, United States
    • Texas
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

November 1, 2003

Study Completion (Actual)

November 1, 2003

Study Registration Dates

First Submitted

November 30, 2006

First Submitted That Met QC Criteria

November 30, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

November 23, 2011

Last Update Submitted That Met QC Criteria

November 22, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCH346B103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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