Clinical trial NCT00407212: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Parkinson's Disease
Keywords: early stage idiopathic Parkinson's disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 301
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
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
measure: Safety assessments as based on the frequency of adverse events and the number of laboratory values that fall outside of the ranges.
Secondary outcomes:
measure: Annual change rates for Unified Parkinsons Disease Rating Scalescore
measure: Changes in UPDRS score after 4 weeks and after withdrawal of study treatment
measure: Percentage of patients needing symptomatic treatment within 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Berkley
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Sunnyvale
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Chicago
country: United States
state: Illinois
city: Southfield
country: United States
state: Michigan
city: Great Falls
country: United States
state: Montana
city: Columbus
country: United States
state: Ohio
city: Pawtucket
country: United States
state: Rhode Island
city: Houston
country: United States
state: Texas
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
city: Curitiba
country: Brazil
facility: Novartis Investigative Site
city: Fortaleza
country: Brazil
facility: Novartis Investigative Site
city: Sao Paolo
country: Brazil
facility: Novartis Investigative Site
city: Caligary
country: Canada
facility: Novartis Investigative Site
city: Hallifax
country: Canada
facility: Novartis Investigative Site
city: Markham
country: Canada
facility: Novartis Investigative Site
city: Montreal
country: Canada
facility: Novartis Investigative Site
city: Vancouver
country: Canada
facility: Novartis Investigative Site
city: Winnipeg
country: Canada
facility: Novartis Investigative Site
city: Clermont
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
city: Paris
country: France
facility: Novartis Investigative Site
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
Study officials:
References: