Widely available drug will be tested for safety and effectiveness in 56 sites in North America
Tanya Simuni, M.D., medical director of Northwestern University's Parkinson's Disease and Movement Disorders Center, was awarded a grant from the National Institutes of Health (NIH) to conduct a $16 million phase III study of the safety and efficacy of the drug isradipine as a potential neuroprotective agent in Parkinson's disease.
This is the only phase III Parkinson's neuroprotective study currently funded by the National Institute of Neurological Disorders and Stroke at NIH. The research is being conducted by Northwestern University Feinberg School of Medicine in partnership with the University of Rochester Medical Center. The study will be carried out at 56 Parkinson Study Group centers in North America over five years.
"If this drug proves to be safe and effective, it will change the way we treat Parkinson's disease," said Simuni, the principal investigator of the study. "The major advantage is isradipine is already widely available and inexpensive and will allow for rapid translation of our research into clinical practice. Although we now have very effective symptomatic treatments to manage Parkinson's, the development of a disease-modifying intervention remains the Holy Grail."
Simuni is the Arthur C. Nielsen, Jr. Research Professor in Parkinson's Disease and Movement Disorders at Feinberg and a neurologist at Northwestern Memorial Hospital.
Parkinson's is the second most common neurodegenerative disease. Prominent traits include tremor, stiffness of the limbs and trunk, slowness of movement and impaired balance and coordination. While there are pharmaceutical and alternative therapies available to manage the disease, there are currently no cures or treatments that definitively slow its progression. Researchers are looking for treatments to delay disease progression. If isradipine proves effective, the drug could revolutionize the treatment of Parkinson's.
Isradipine has been approved by the Food and Drug Administration as a calcium-channel blocker to treat hypertension (high blood pressure). By inhibiting the excessive flow of calcium, it may also stunt certain adverse cellular functions.
Researchers have speculated that imbalances in calcium may contribute to cellular toxicity and the death of dopamine-producing neurons in the brain that lead to Parkinson's. Dopamine is a critical chemical messenger in the brain that directs a person's ability to move. It is hypothesized that isradipine will slow the progression of the disease by protecting dopamine-producing neurons from toxicity over an extended period of time.
Academic colleagues at Feinberg will collaborate with Simuni on this study, including D. James Surmeier, the Nathan Smith Davis Professor of Physiology and director of the Udall Center of Excellence for Parkinson's Disease Research. Surmeier, the chair of physiology, and his team of researchers discovered the possible relationship between isradipine and Parkinson's disease. The physiology department Surmeier heads is one of the nation's premier groups studying the physiology of movement disorders.