A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00399477 |
Recruitment Status :
Completed
First Posted : November 14, 2006
Last Update Posted : April 12, 2011
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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 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 |

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
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Drug: Rasagiline mesylate plus Mirapex
Mirapex, Azilect® Drug: Rasagiline mesylate with Levodopa Azilect®, Levodopa Drug: Rasagiline mesylate with Requip Azilect®, Requip |
- To identify the earliest scheduled visit of symptomatic effect [ Time Frame: 8 months ]
- To characterize the effectiveness of Azilect in a usual community neurological [ Time Frame: 8 months ]

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Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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Requiring therapy for PD symptom control
- Azilect monotherapy.
- Azilect as adjunct therapy..
Exclusion Criteria:
- Patients previously exposed to Azilect
- Patients with pheochromocytoma
- Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.

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
Study Director: | MerriKay Oleen-Burkey, PhD | Teva Neuroscience, Inc. |
Responsible Party: | Thomas Smith, MD, Teva Neuroscience |
ClinicalTrials.gov Identifier: | NCT00399477 |
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 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Levodopa 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 Antioxidants Dopamine Agonists |