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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 30, 2006
Last Updated Date	November 22, 2011
Start Date ^ICMJE	January 2002
Primary Completion Date	November 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 29, 2007)	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.
Original Primary Outcome Measures ^ICMJE (submitted: November 30, 2006)	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.
Change History	Complete list of historical versions of study NCT00407212 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 30, 2006)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy
Official Title ^ICMJE	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
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Parkinson's Disease
Intervention ^ICMJE	Drug: TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	301
Completion Date	November 2003
Primary Completion Date	November 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	30 Years to 80 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Brazil, Canada, France, Germany, Italy, Netherlands, Portugal, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00407212
Other Study ID Numbers ^ICMJE	TCH346B103
Has Data Monitoring Committee	Not Provided
Responsible Party	Novartis
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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