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

Sponsor:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00399477

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: Azilect (rasagiline mesylate) Drug: Mirapex Drug: Levodopa Drug: Requip	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Rasagiline Rasagiline mesylate

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

To identify the earliest scheduled visit at which the symptomatic effect of
Azilect as initial monotherapy and as adjunct therapy can be demonstrated

Secondary Outcome Measures:

To characterize the effectiveness of Azilect in a usual community neurological
practice by assessing investigator and patient-rated satisfaction and ease-of-use.

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

Detailed Description:

Open-label, multicentered Two hundred-fifty (250) enrolled patients will be stratified within each center by absence/presence of concomitant dopaminergic therapy

Azilect as monotherapy: Patients not currently receiving LD/CD or a dopamine agonist; Azilect as first line dopaminergic PD treatment
Azilect as adjunct therapy: Patients already receiving LD/CD and/or dopamine agonist
Approx. 1:1 ratio of mono- to adjunct therapy, for the study overall. Visits at Screening/Baseline, Weeks 1, 2, 4, and 12. Telephone contact at Week 8.

PD symptom scales, satisfaction/ease-of-use ratings, global evaluations and safety assessments to be completed by investigator and/or patient at baseline and at specified visits during the study.

For patients receiving Azilect as adjunct therapy, the use and dose changes of LD/CD and /or dopamine agonists will be recorded in detail.

Eligibility

Ages Eligible for Study:	30 Years and older
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

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

Hide Study Locations

Locations

United States, Arizona
Hope Research Institute, LLC
Phoenix, Arizona, United States, 85050
Neurological Physicians of Arizona
Mesa, Arizona, United States, 85201
United States, California
Neuro-Therapeutic, Inc.
Pasadena, California, United States, 91105
Coastal Neurology Medical Group
La Jolla, California, United States, 92037
Neurological Institute of the East Bay
Walnut Creek, California, United States, 94596
Neurophysiologic Laboratory
Laguna Hills, California, United States, 92653
Neurology Center of North Orange County
La Habra, California, United States, 90631
United States, Colorado
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States, 90910
United States, Connecticut
Associated Neurologists of Southern Connecticut, P.C.
Fairfield, Connecticut, United States, 06460
United States, Florida
Collier Neurologic Specialitsts
Naples, Florida, United States, 34102
Neurological Associates P.A.
Maitland, Florida, United States
Sunrise Clinical Research
Hollywood, Florida, United States, 33021
Neurological Associates, PA
Pompano Beach, Florida, United States, 33060
Stein and Sutherland Neurology
Sarasota, Florida, United States, 34239
United States, Georgia
Neurology & Headache Specialists of Atlanta
Decatur, Georgia, United States
Neurology Specialist of Savannah
Savannah, Georgia, United States, 31406
United States, Illinois
Neurology Specialists of Northern Illinios
Des Plains, Illinois, United States, 60016
South Suburban Neurology, LTD
Flossmoor, Illinois, United States, 60422
United States, Maryland
Parkinson Disease and Movement Disorder Center of Maryland
Elkridge, Maryland, United States, 21075
United States, Massachusetts
South Shores Neurology Associates, INC
South Weymouth, Massachusetts, United States, 02190
United States, Michigan
St. Mary's Mercy Medical Center
Grand Rapids, Michigan, United States, 49503
Michigan Medical, P.C.
Grand Rapids, Michigan, United States, 49525
United States, Minnesota
Mankato Clinic
Mankato, Minnesota, United States, 56001
United States, Missouri
The Division of Neurology @ St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, Montana
Montana Neurobehavioral Specialists
Missoula, Montana, United States, 59807
United States, New Hampshire
Coastal Neurology Services, Inc.
Dover, New Hampshire, United States, 03820
United States, New Jersey
Neurology Group of Bergen County, PA
Ridgewood, New Jersey, United States, 07450
United States, New York
Alpha Neurology
Staten Island, New York, United States
United States, North Carolina
Asheville Neurology Specialist, PA
Asheville, North Carolina, United States, 28806
Central Carolina Neurology & Sleep
Salisbury, North Carolina, United States, 28144
Neurology Consultants of the Carolinas
Charlotte, North Carolina, United States, 28204
United States, Ohio
NeuroCare Center
Canton, Ohio, United States, 44718
United States, Oregon
Medford Neurological Clinic,Inc
Medford, Oregon, United States, 97504
United States, Pennsylvania
Parkinson Disease and Movement Disorder Center
Upland, Pennsylvania, United States, 19013
United States, Tennessee
Brentwood Neurology
Brentwood, Tennessee, United States, 37027
United States, Texas
Neurology Associates
San Antonio, Texas, United States, 78252
Neurology Specialists of Dallas
Dallas, Texas, United States, 75231
United States, Virginia
Blue Ridge Research
Roanoke, Virginia, United States, 24018
United States, Washington
Booth Gardner Parkinson's Care Center
Kirkland, Washington, United States, 98034
United States, West Virginia
Neurology Clinic, Inc
Lewisburg, West Virginia, United States, 56002

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

MerriKay Oleen-Burkey, PhD

Teva Neuroscience, Inc.

More Information

No publications provided

Study ID Numbers:	TVP-1012/PM101
Study First Received:	November 10, 2006
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00399477 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Rasagiline
Molecular Mechanisms of Pharmacological Action
Basal Ganglia Diseases
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Enzyme Inhibitors
Brain Diseases
Neurodegenerative Diseases

Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Monoamine Oxidase Inhibitors
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009