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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00407212 |
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Date of registration:
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30/11/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy
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Scientific title:
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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 |
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Date of first enrolment:
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January 2002 |
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Target sample size:
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301 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00407212 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Brazil
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Canada
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France
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Germany
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Italy
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Netherlands
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Portugal
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)
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Primary Outcome(s)
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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
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Safety assessments as based on the frequency of adverse events and the number of laboratory values that fall outside of the ranges.
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Secondary Outcome(s)
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Percentage of patients needing symptomatic treatment within 12 months
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Annual change rates for Unified Parkinsons Disease Rating Scalescore
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Changes in UPDRS score after 4 weeks and after withdrawal of study treatment
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Secondary ID(s)
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TCH346B103
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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