Apr 29, 2008 - 4:38:53 PM
(HealthNewsDigest.com) - ST. LOUIS – Researchers at Saint Louis University are preparing to test an investigational pill to treat relapsing-remitting multiple sclerosis, the most common form of the potentially disabling neurological disease.
There are currently no oral medications approved to treat MS, which affects some 400,000 people in the United States (with approximately 10,000 new cases diagnosed each year). There are various medications to slow or modify the progression of the disease, but all must be injected into the skin, muscle or veins, making the search for an oral medication a top priority.
SLU will be one of several dozen sites around the world where researchers will study how patients with relapsing-remitting MS respond to the experimental drug laquinimod, which is taken in tablet form once a day. About 1,000 patients will be enrolled worldwide.
MS is a disease in which the body’s immune system attacks the protective coating – called myelin – surrounding the nerves within the central nervous system, as well as the nerve fibers themselves. Symptoms can vary widely from person to person, but they generally include fatigue, muscle weakness, numbness, impaired mobility, balance and cognition and vision disturbances.
About 85 percent of people newly diagnosed with the disease have relapsing-remitting MS. This form of the disease is characterized by periodic attacks or flare-ups (relapses), followed by months or even years of little to no signs of the disease (remission).
“Laquinimod seems to modulate how the immune system works,” said Florian P. Thomas, M.D., Ph.D., professor of neurology at the Saint Louis University School of Medicine and the study’s principal investigator. “In smaller, earlier trials, the drug reduced the likelihood of relapses in patients, as well as the number of MS lesions seen on MRI tests.”
In the randomized, double-blind study – the largest such investigation of the drug to date – half the volunteers will receive laquinimod while the remainder will be given a placebo.
They’ll remain in the trial for up to 30 months, during which time researchers will periodically assess how their disease develops. At various visits throughout the trial, patients will be given complete physical and neurological examinations, as well as an MRI scan to determine the extent of scarring on the brain – a defining characteristic of multiple sclerosis.
For the study, SLU researchers are looking for patients with relapsing-remitting MS between the ages of 18 and 55. Among other criteria, patients must not have taken any immuno-suppressive drugs within the last six months. Women must not be pregnant or breast feeding, and those of child-bearing age must be on at least two forms of birth control.
People wanting more information or to find out whether they qualify to participate in the study should call 314-977-4900.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.
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