Back to resultsA Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring early stage idiopathic Parkinson's disease
Eligibility 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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00407212
Brief Title
A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
early stage idiopathic Parkinson's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
301 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)
Primary Outcome Measure Information:
Title
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
Title
Safety assessments as based on the frequency of adverse events and the number of laboratory values that fall outside of the ranges.
Secondary Outcome Measure Information:
Title
Annual change rates for Unified Parkinsons Disease Rating Scalescore
Title
Changes in UPDRS score after 4 weeks and after withdrawal of study treatment
Title
Percentage of patients needing symptomatic treatment within 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Eligibility 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
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Berkley
State/Province
California
Country
United States
City
Fountain Valley
State/Province
California
Country
United States
City
Sunnyvale
State/Province
California
Country
United States
City
New Haven
State/Province
Connecticut
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Southfield
State/Province
Michigan
Country
United States
City
Great Falls
State/Province
Montana
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Pawtucket
State/Province
Rhode Island
Country
United States
City
Houston
State/Province
Texas
Country
United States
Facility Name
Novartis Investigative Site
City
Belo Horizonte
Country
Brazil
Facility Name
Novartis Investigative Site
City
Curitiba
Country
Brazil
Facility Name
Novartis Investigative Site
City
Fortaleza
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paolo
Country
Brazil
Facility Name
Novartis Investigative Site
City
Caligary
Country
Canada
Facility Name
Novartis Investigative Site
City
Hallifax
Country
Canada
Facility Name
Novartis Investigative Site
City
Markham
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
Country
Canada
Facility Name
Novartis Investigative Site
City
Vancouver
Country
Canada
Facility Name
Novartis Investigative Site
City
Winnipeg
Country
Canada
Facility Name
Novartis Investigative Site
City
Clermont
Country
France
City
Marseille
Country
France
Facility Name
Novartis Investigative Site
City
Paris
Country
France
City
St. Herblain
Country
France
City
Tours
Country
France
City
Berlin
Country
Germany
City
Bochum
Country
Germany
City
Leipzig
Country
Germany
City
Wiesbaden
Country
Germany
City
Genova
Country
Italy
City
Lido di Camaiore
Country
Italy
City
Maples
Country
Italy
City
Milan
Country
Italy
City
Pescara
Country
Italy
City
Amsterdam
Country
Netherlands
City
Bedra
Country
Netherlands
City
Biaricum
Country
Netherlands
City
Den Bosch
Country
Netherlands
City
Dordrecht
Country
Netherlands
City
Groningen
Country
Netherlands
City
Lisboa
Country
Portugal
City
Birmingham
Country
United Kingdom
City
Cambridge
Country
United Kingdom
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy
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