Company Press Release
SOURCE: National Parkinson Foundation
Parkinson's Disease Patients Sought for Phase III Clinical Trial - Trial
to Examine Delay of Disease Progression -
MIAMI, Jan. 28, 1999 /PRNewswire/ -- A clinical trial examining the
potential to delay the progression of Parkinson's disease is now seeking
patients for enrollment. Parkinson's disease patients, ages 40-80, with
recent, untreated symptoms are being sought at 43 clinical sites in the
United States. Parkinson's disease is a progressive, degenerative
brain disorder that affects an estimated 1.5 million Americans, with
more than 50,000 new cases diagnosed each year. Parkinson's disease
symptoms worsen over time and include tremor of the arms and legs,
rigidity and stiffness of muscles, and slowness of movement known as
bradykinesia.
Research with experimental Parkinson's disease animal models suggests
that Rilutek® (riluzole) tablets, the first drug approved for treating
amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease, may slow
down the progression of Parkinson's disease. The exact mechanism of
action of Rilutek is unknown.
``Presently, we are only able to treat the symptoms of Parkinson's
disease,'' said Dr. C. Warren Olanow, chairman of the Department of
Neurology at the Mount Sinai School of Medicine in New York City. ``This
study will test our ability to slow the progression of this devastating
disease.''
``We strongly encourage members of the Parkinson's community to enroll
in this promising phase III clinical trial. The information that we hope
to obtain is critical to the millions of people who either suffer from
Parkinson's disease or who are at risk of getting it,'' noted Dr.
Abraham Lieberman, national medical director of the National Parkinson
Foundation (NPF).
Michael J. Fox, the 37-year-old actor who recently revealed his
seven-year battle with Parkinson's, is among the approximately 10
percent of patients under the age of 40 who are stricken with the
disease early in life. Affecting one out of 100 people in the over-60
population, the average age of onset of Parkinson's is usually 55-60.
Eighty-five
percent of patients are diagnosed after age 50.
``As the world population ages and specifically baby boomers enter their
elderly years, Parkinson's disease will become an even greater public
health issue in this country,'' added Dr. Lieberman.
While it has no known cause or cure, Parkinson's disease occurs when
nerve cells producing the brain chemical dopamine die. Eighty percent of
dopamine-producing cells die in Parkinson's patients impairing their
ability to produce smooth controlled movements. Such nerve cell death
often results in the stooped posture, slurred speech and slow,
shuffling walk characteristic of Parkinson's disease. Although the rate
of the disease's progression varies in each individual and the disease
itself is not fatal, late stage Parkinson's patients are often unable to
walk, talk or care for themselves.
Patients enrolled in this phase III clinical trial will receive
treatment (riluzole or placebo) for two years. Riluzole was approved for
ALS in the U.S. in 1995 and has since been approved in 44 other
countries. The drug's most common side effects in ALS patients are
asthenia (fatigue), nausea, and elevated liver enzymes. Side effects in
patients with
Parkinson's disease are not known. Patient recruitment for the phase III
clinical trial using riluzole in Parkinson'sdisease patients is underway
via an 800 number. Individuals who are 40-80 years old, diagnosed with
Parkinson's disease within the last 3 years and not currently receiving
anti-Parkinson medication are encouraged to call the 800 number. To
learn the location of a study site and additional enrollment criteria,
please call 1-800-220-8610 or visit Centerwatch at
http://www.centerwatch.com or RPR's Internet website at
http://www.rp-rorer.com.
--
Judith Richards, London, Ontario, Canada
<[log in to unmask]>
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