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
1 other identifier
interventional
301
9 countries
45
Brief Summary
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2002
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 30, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedNovember 23, 2011
November 1, 2011
1.8 years
November 30, 2006
November 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (45)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Berkley, California, United States
Unknown Facility
Fountain Valley, California, United States
Unknown Facility
Sunnyvale, California, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Southfield, Michigan, United States
Unknown Facility
Great Falls, Montana, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Pawtucket, Rhode Island, United States
Unknown Facility
Houston, Texas, United States
Novartis Investigative Site
Belo Horizonte, Brazil
Novartis Investigative Site
Curitiba, Brazil
Novartis Investigative Site
Fortaleza, Brazil
Novartis Investigative Site
São Paulo, Brazil
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
Novartis Investigative Site
Clermont, France
Unknown Facility
Marseille, France
Novartis Investigative Site
Paris, France
Unknown Facility
Saint-Herblain, France
Unknown Facility
Tours, France
Unknown Facility
Berlin, Germany
Unknown Facility
Bochum, Germany
Unknown Facility
Leipzig, Germany
Unknown Facility
Wiesbaden, Germany
Unknown Facility
Genova, Italy
Unknown Facility
Lido di Camaiore, Italy
Unknown Facility
Maples, Italy
Unknown Facility
Milan, Italy
Unknown Facility
Pescara, Italy
Unknown Facility
's-Hertogenbosch, Netherlands
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Bedra, Netherlands
Unknown Facility
Biaricum, Netherlands
Unknown Facility
Dordrecht, Netherlands
Unknown Facility
Groningen, Netherlands
Unknown Facility
Lisbon, Portugal
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
Cambridge, United Kingdom
Unknown Facility
Sheffield, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2006
First Posted
December 4, 2006
Study Start
January 1, 2002
Primary Completion
November 1, 2003
Study Completion
November 1, 2003
Last Updated
November 23, 2011
Record last verified: 2011-11