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

November 30, 2006
November 22, 2011
January 2002
November 2003   (final data collection date for primary 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.
  • 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.
Complete list of historical versions of study NCT00407212 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Parkinson's Disease
Drug: TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
301
November 2003
November 2003   (final data collection date for primary outcome measure)

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

Both
30 Years to 80 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Canada,   France,   Germany,   Italy,   Netherlands,   Portugal,   United Kingdom
 
NCT00407212
TCH346B103
Not Provided
Novartis
Novartis
Not Provided
Not Provided
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP