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

Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)

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 Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: rasagiline mesylate; Drug: Rasagiline mesylate plus Mirapex; Drug: Rasagiline mesylate with Levodopa; Drug: Rasagiline mesylate with Requip

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rasagiline mesylate	Drug: rasagiline mesylate; Azilect®
Experimental: Rasagiline mesylate plus adjunct therapy; Rasagiline mesylate with one of three adjunct therapies	Drug: Rasagiline mesylate plus Mirapex; Mirapex, Azilect®; Drug: Rasagiline mesylate with Levodopa; Azilect®, Levodopa; Drug: Rasagiline mesylate with Requip; Azilect®, Requip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To identify the earliest scheduled visit of symptomatic effect	8 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To characterize the effectiveness of Azilect in a usual community neurological	8 months

Collaborators and Investigators

• Sponsor: Teva Neuroscience, Inc.
• Investigators: Study Director: MerriKay Oleen-Burkey, PhD, Teva Neuroscience, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: November 10, 2006
• First Submitted That Met QC Criteria: November 13, 2006
• First Posted (Estimate): November 14, 2006

Study Record Updates

• Last Update Posted (Estimate): April 12, 2011
• Last Update Submitted That Met QC Criteria: April 8, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Dopamine Agonists; Dopamine Agents; Monoamine Oxidase Inhibitors; Antioxidants; Antiparkinson Agents; Anti-Dyskinesia Agents; Rasagiline; Levodopa; Pramipexole
• Other Study ID Numbers: TVP-1012/PM101