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

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ClinicalTrials.gov Identifier: NCT00399477
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : April 12, 2011
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: rasagiline mesylate Drug: Rasagiline mesylate plus Mirapex Drug: Rasagiline mesylate with Levodopa Drug: Rasagiline mesylate with Requip Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)
Study Start Date : October 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. To identify the earliest scheduled visit of symptomatic effect [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. To characterize the effectiveness of Azilect in a usual community neurological [ Time Frame: 8 months ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399477


Sponsors and Collaborators
Teva Neuroscience, Inc.
Investigators
Study Director: MerriKay Oleen-Burkey, PhD Teva Neuroscience, Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Thomas Smith, MD, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00399477     History of Changes
Other Study ID Numbers: TVP-1012/PM101
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Ropinirole
Pramipexole
Rasagiline
 Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Protective Agents
Dopamine Agonists
Antioxidants