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

Condition(s) targeted: Parkinson's Disease

Intervention: Azilect (rasagiline mesylate) (Drug); Mirapex (Drug); Levodopa (Drug); Requip (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Teva Pharmaceutical Industries

Official(s) and/or principal investigator(s):
MerriKay Oleen-Burkey, PhD, Study Director, Affiliation: Teva Neuroscience, Inc

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.

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 design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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:

To characterize the effectiveness of Azilect in a usual community neurological

practice by assessing investigator and patient-rated satisfaction and ease-of-use.

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.

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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.

Hope Research Institute, LLC, Phoenix, Arizona 85050, United States

Neurological Physicians of Arizona, Mesa, Arizona 85201, United States

Neuro-Therapeutic, Inc., Pasadena, California 91105, United States

Coastal Neurology Medical Group, La Jolla, California 92037, United States

Neurological Institute of the East Bay, Walnut Creek, California 94596, United States

Neurophysiologic Laboratory, Laguna Hills, California 92653, United States

Neurology Center of North Orange County, La Habra, California 90631, United States

Colorado Springs Neurological Associates, Colorado Springs, Colorado 90910, United States

Associated Neurologists of Southern Connecticut, P.C., Fairfield, Connecticut 06460, United States

Collier Neurologic Specialitsts, Naples, Florida 34102, United States

Neurological Associates P.A., Maitland, Florida, United States

Sunrise Clinical Research, Hollywood, Florida 33021, United States

Neurological Associates, PA, Pompano Beach, Florida 33060, United States

Stein and Sutherland Neurology, Sarasota, Florida 34239, United States

Neurology & Headache Specialists of Atlanta, Decatur, Georgia, United States

Neurology Specialist of Savannah, Savannah, Georgia 31406, United States

Neurology Specialists of Northern Illinios, Des Plains, Illinois 60016, United States

South Suburban Neurology, LTD, Flossmoor, Illinois 60422, United States

Parkinson Disease and Movement Disorder Center of Maryland, Elkridge, Maryland 21075, United States

South Shores Neurology Associates, INC, South Weymouth, Massachusetts 02190, United States

St. Mary's Mercy Medical Center, Grand Rapids, Michigan 49503, United States

Michigan Medical, P.C., Grand Rapids, Michigan 49525, United States

Mankato Clinic, Mankato, Minnesota 56001, United States

The Division of Neurology @ St. John's Mercy Medical Center, St. Louis, Missouri 63141, United States

Montana Neurobehavioral Specialists, Missoula, Montana 59807, United States

Coastal Neurology Services, Inc., Dover, New Hampshire 03820, United States

Neurology Group of Bergen County, PA, Ridgewood, New Jersey 07450, United States

Alpha Neurology, Staten Island, New York, United States

Asheville Neurology Specialist, PA, Asheville, North Carolina 28806, United States

Central Carolina Neurology & Sleep, Salisbury, North Carolina 28144, United States

Neurology Consultants of the Carolinas, Charlotte, North Carolina 28204, United States

NeuroCare Center, Canton, Ohio 44718, United States

Medford Neurological Clinic,Inc, Medford, Oregon 97504, United States

Parkinson Disease and Movement Disorder Center, Upland, Pennsylvania 19013, United States

Brentwood Neurology, Brentwood, Tennessee 37027, United States

Neurology Associates, San Antonio, Texas 78252, United States

Neurology Specialists of Dallas, Dallas, Texas 75231, United States

Blue Ridge Research, Roanoke, Virginia 24018, United States

Booth Gardner Parkinson's Care Center, Kirkland, Washington 98034, United States

Neurology Clinic, Inc, Lewisburg, West Virginia 56002, United States

Starting date: October 2006
Last updated: July 30, 2007