Hershey, Pa. --- A multi-center clinical research trial is underway to test a new drug to treat diabetic neuropathy, a common complication of diabetes that impairs nerve function in the lower extremities and can lead to foot ulcers and sometimes amputation.
The drug is known as PN401 and was developed by Pro-Neuron Inc. of Gaithersburg, MD.
" Nerves conduct electrical signals to the arms and legs. When this doesn't work properly, it is called neuropathy. This drug shows great promise to improve nerve conduction for patients with diabetic neuropathy," says Zachary Simmons, M.D., associate professor of medicine at Penn State's College of Medicine.
Simmons is also a physician with the Penn State Geisinger Health System, and the director of the neuromuscular program at the Hershey Medical Center, which is one of five study sites throughout the country that are currently enrolling patients.
"Currently there is not treatment for diabetic neuropathy. We can only treat the diabetes which, at best, will stabilize the neuropathy," says Simmons. "Right now we only give patients medication for pain. This drug specifically may work to treat the neuropathy. We have great hope since about 70 percent of the eight million diabetics in the United States are affected by neuropathy."
Although the exact cause of diabetic neuropathy is unknown, excessive glucose levels can, over time, decrease nerve function. The condition results in pain, numbness and sometimes weakness in the lower extremities, and to a lesser degree in the hands and arms.
Simmons, as well as other physicians involved in the trial, are looking for patients to enroll in the study. To be considered for the trial, patients should have had diabetes for at least five years. The diabetes must be fairly well controlled, and patients should have no other health problems. Also, patients should have only mild to moderate diabetic neuropathy to be considered for this study.
"We will do nerve conduction tests before the drug is given and then at various times after the drug is administered to see if the drug is working," says Simmons. "If this phase two trial shows promising results regarding nerve conduction velocities, we would likely move to a phase three trial. That would mean not only looking for improved nerve conduction but also to see if the drug reduces pain and numbness."
This drug has not yet been approved by the FDA. There is no charge to patients to participate in this study.
Patients or family members interested in the PN401 trial at Hershey Medical Center should contact Tamara Murphy, B.S.N., R.N., the study coordinator, at (717)531-8692.
This study has been approved by the Institutional Review Board at Penn State's College of Medicine following FDA regulations. If you want more information about other study sites around the country, contact Pro-Neuron, Inc., at (301)984-8554.