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April 16, 2014

Researchers set to launch Phase 3 trial for Parkinson’s

Study to investigate blood-pressure drug’s effectiveness in treating Parkinson’s disease

A $23 million grant from the National Institutes of Health will support a new Phase 3 clinical trial to evaluate the drug isradipine as a potential new treatment for Parkinson’s disease. The study is being colead by Rochester and Northwestern University.

“Isradipine has been demonstrated to be safe and tolerable in patients with Parkinson’s disease,” says School of Medicine and Dentistry neurologist Kevin Biglan, coprincipal investigator of the study. “This new study will determine whether the drug can be an effective tool in slowing the progression of the disease and could, thereby, complement existing symptomatic treatments and improve the quality of life of individuals with the disease.”

“If it proves to be effective, this drug will change the way we treat Parkinson’s disease, and the major advantage of it is that isradipine is already widely available, inexpensive and will allow for rapid translation of our research into clinical practice,” says Tanya Simuni, principal investigator of the study, professor of neurology at Northwestern University Feinberg School of Medicine. “Although we now have very effective symptomatic treatments to manage Parkinson’s, the development of a disease-modifying intervention remains a critical goal.”

Isradipine is a Food and Drug Administration–approved drug to treat high blood pressure. Researchers suspect that the drug may also be effective in treating Parkinson’s for a couple reasons. First, studies have shown that people taking the drug for high blood pressure have a lower incidence of Parkinson’s disease. Additionally, isradipine is in a category of drugs called calcium channel blockers, meaning they inhibit certain cellular functions. Researchers speculate that overactive calcium channels may play a role in the death of the dopamine–producing cells in the brain that is one of the hallmarks of Parkinson’s.

Parkinson’s disease is a progressive neurological disorder that erodes patients’ control over movements and speech. Over time, people with Parkinson’s experience stiffness or rigidity of their arms and legs, slowness or lack of movement, and walking difficulties, in addition to tremors in their hands, arms, legs, jaw, or face.

The new clinical trial—titled STEADY-PD3—will recruit 336 individuals with Parkinson’s disease at 56 sites throughout North America, including Rochester. The study—which is scheduled to begin recruiting Parkinson’s patients later this year—will follow the participants for three years. The primary goal is to determine whether the drug can slow the progression of the disease.

“We have good early stage treatments for the symptoms of Parkinson’s disease, and individuals who have problems with mobility and coordination can often get back to where they can function at a very high level,” says Biglan. “However, over the long term, problems arise due to disease progression, and people become less responsive to therapy. If you could slow the progression sufficiently enough, then with existing symptomatic treatments you could manage Parkinson’s symptoms quite well over a much longer period of time.”

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