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

Purpose

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	Intervention	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
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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)

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Ropinirole hydrochloride Ropinirole Pramipexole dihydrochloride Pramipexole Rasagiline mesylate

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

To identify the earliest scheduled visit of symptomatic effect [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To characterize the effectiveness of Azilect in a usual community neurological [ Time Frame: 8 months ] [ Designated as safety issue: No ]


Enrollment:	200
Study Start Date:	October 2006
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	30 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.
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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399477

Sponsors and Collaborators

Teva Neuroscience, Inc.

Investigators


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

More Information


Responsible Party:	Thomas Smith, MD, Teva Neuroscience
ClinicalTrials.gov Identifier:	NCT00399477 History of Changes
Other Study ID Numbers:	TVP-1012/PM101
Study First Received:	November 10, 2006
Last Updated:	April 8, 2011
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016