NEW YORK, NY— The Michael J. Fox Foundation announced that it has awarded $1.1 million for an international clinical trial vetting the potential of a nicotine skin patch to modify the progression of Parkinson’s disease. The funding was made under the Clinical Intervention Awards initiative, one of MJFF’s Edmond J. Safra Core Programs for PD Research.
This first-ever multisite, investigator-initiated collaboration between Parkinson’s study groups in Germany and the United States will encompass a one-year double-blind, placebo-controlled trial in 150 newly diagnosed Parkinson’s patients. Principal investigators Wolfgang H. Oertel and Marcus M. Unger of Phillipps University Marburg, Germany, and Karl Kieburtz of the University of Rochester, New York, will evaluate the disease-modifying potential of transdermal nicotine using standard skin patches of the type used by millions of smokers as a quitting aid. The production of the patches being used in this trial has been supported by the pharmaceutical company Novartis.
While scientists have previously studied the symptomatic effects of nicotine in Parkinson’s patients, this is the first long-term clinical trial expressly designed to test whether nicotine may in fact modify the progression of PD. Parkinson’s researchers have long been intrigued by epidemiological research showing a possible link between cigarette smoking and a lowered risk of PD: the disease is far less prevalent among smokers compared to never-smokers. Nicotine also has demonstrated beneficial effects on PD in pre-clinical studies. Yet key questions about the relationship among smoking, nicotine and Parkinson’s — including whether smoking tobacco products in fact confers protection and, if so, whether this protection stems from the nicotine in those products — remain unanswered.
Until this trial provides data on the safety profile of transdermal nicotine in never-smokers, the study leaders caution that patients should not introduce nicotine into their treatment regimen without the explicit recommendation of their doctor. The benefits of transdermal nicotine for PD have not yet been conclusively proven, and its safety for use in people who have never smoked remains unestablished. Trial participants will be closely monitored for any adverse health effects that may occur as a result of nicotine treatment.
The commercialization of a therapy capable of retarding or stopping the progression of Parkinson’s disease — rather than merely masking symptoms while the underlying disease continues to worsen — would be a transformative event in the lives of the estimated 5 million Parkinson’s patients worldwide. Transdermal nicotine holds the additional advantages of wide availability and relatively low cost.
The investigators expect to begin enrolling patients in summer 2010. As with all MJFF awards, continued funding is dependent on researchers’ achieving predetermined milestones. Progress and outcome reports will be posted to the Foundation’s Web site as they become available.