A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease

Teva Neuroscience, Inc.200 enrolled

Overview

Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at their first visit based on the drugs they are taking for their PD: * Group 1 Patients using Azilect and no other therapy. * Group 2 Azilect in combination with other medications like Levodopa, Mirapex, or Requip.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Parkinson's Disease

Interventions

rasagiline mesylateDRUG

Azilect®

Rasagiline mesylate plus MirapexDRUG

Mirapex, Azilect®

Rasagiline mesylate with LevodopaDRUG

Azilect®, Levodopa

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Idiopathic Parkinson's disease. Diagnosis previously confirmed by the presence of bradykinesia and by at least one additional cardinal sign (i.e., resting tremor, rigidity), without other known or suspected cause of parkinsonism. 2. Requiring therapy for PD symptom control * Azilect monotherapy. * Azilect as adjunct therapy.. Exclusion Criteria: 1. Patients previously exposed to Azilect 2. Patients with pheochromocytoma 3. Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.

Outcomes

Primary Outcomes

To identify the earliest scheduled visit of symptomatic effect

Time frame: 8 months

Secondary Outcomes

To characterize the effectiveness of Azilect in a usual community neurological

Time frame: 8 months

Data from ClinicalTrials.gov

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