Richard Lewis, M.D.
The study will evaluate the safety and effectiveness of intravenous injection of ceftriaxone in the treatment of ALS.
An antibiotic, ceftriaxone has attracted the interests of medical researchers because a number of studies suggest the drug may protect motor neurons from injury. Researchers involved in the study hope that the drug will slow the rate of ALS progression.
“While we don’t know ceftriaxone will be of benefit to ALS patients, our hope is that it will slow the rate of the disease’s progression,” said Richard Lewis, M.D., director of the Hiller ALS Clinic and professor and associate chairman of the Department of Neurology and co-director of the Neuromuscular Program at the Wayne State University School of Medicine. “The knowledge that researchers gain from this study may present great future benefits for ALS sufferers.”
Dr. Lewis and Agnes Jani-Acsadi, M.D., are the principal investigators of the study for the School of Medicine and the Hiller Center.
The NIH has approved a $20 million grant to study the drug’s effects on ALS at 60 medical centers across the country. In addition to the Hiller ALS Clinic and Research Center, Henry Ford Health System and St. Mary’s Healthcare in Grand Rapids are taking part in the study.
Medical researchers know that motor neurons die in the brains and spinal cords of those afflicted with ALS, but they don’t yet know why. They theorize that increased levels of the chemical glutamate may be related to neuron death. Ceftriaxone may increase levels of a protein that decreases glutamate levels near nerves.
While approved by the U.S. Food and Drug Administration for treating bacterial infections, the drug has not been OK’d for treating ALS.
Six-hundred people nationwide will be enrolled in the study.
To take part in the study, patients’ ALS symptoms must be no older than three years and they must have a vital breathing capacity of at least 60 percent. They also must have a caregiver available to administer the medication through a central venous catheter twice a day.
Throughout the length of the study, researchers will need to collect blood and urine samples, test the strength of patients’ arms and legs as well as breathing capacity, and interview patients. Patients will need to visit the Hiller Center every week or two for the first several weeks, and then every four weeks for the length of the study. The study will be completed when the last participant registered undergoes 52 weeks of treatment.
Since this a double-blind, placebo-controlled study, neither patients nor the medical staff will know which patients receive the drug. Patients enrolled in the study have a two in three chance of receiving ceftriaxone.
For more information on the study or for questions about participating, call Stacey Masse, R.N., at (313) 745-6124.