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Michael J. Fox Foundation Awards $2.2 Million to Four Clinical Trials for New Parkinson's Interventions

Wednesday, November 11, 2009 General News J E 4
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Focus on complications of treatment, patients' unmet needs

NEW YORK, Nov. 10 /PRNewswire-USNewswire/ -- The Michael J. Fox Foundation for Parkinson's Research announced awards totaling about $2.2 million to four research teams conducting new clinical research in Parkinson's disease.

Two teams will undertake trials to address complications brought on by currently available treatments for Parkinson's disease:

Anders Bjorklund, MD, PhD, of Lund University (Sweden) and colleagues have been funded by MJFF since 2005 to advance their hypothesis that the brain's serotonin system plays a role in dyskinesia, the excessive movements brought on by long-term dopamine replacement therapy. Now the team is initiating a pilot study of eltoprazine, a drug candidate capable of blocking inappropriate release of dopamine from serotonin terminals. The one-year pilot study will enroll 24 Parkinson's patients with dyskinesia at two sites in Sweden. If eltoprazine proves effective in alleviating dyskinesia, the pilot study could lead to a larger clinical trial.

Daniel Weintraub, MD, of the University of Pennsylvania will conduct the first placebo-controlled trial of an agent to treat impulse control disorders associated with certain Parkinson's disease treatments known as dopamine agonists. Naltrexone, which blocks opioid receptors, is approved by the U.S. Food and Drug Administration (FDA) for the treatment of alcohol dependence and has shown a benefit for pathological gambling; it has also been shown to be safe and well-tolerated in people with PD. In this three-year study, Dr. Weintraub will explore its safety and efficacy against impulse control disorders in 48 Parkinson's patients diagnosed with one or more impulse control disorders that developed in the context of dopamine agonist treatment.

Two other teams will investigate non-pharmacological interventions with potential to address Parkinson's patients' unmet needs.

Alvaro Pascual-Leone, MD, PhD, of Harvard Medical School will test the potential of noninvasive repetitive transcranial magnetic stimulation (rTMS) to improve both motor and mood symptoms in Parkinson's disease. In October 2008, rTMS was approved by the FDA for the treatment of major depression outside the context of PD. It has also shown promise to alleviate the motor symptoms of Parkinson's. Dr. Pascual-Leone and colleagues, working at four North American sites, will enroll 160 Parkinson's patients whose motor symptoms are significant despite medication and who have been diagnosed with a depressive disorder. The researchers predict that rTMS will improve motor symptoms, depression, or both.

Daniel Tarsy, MD, of Harvard Medical School will lead the "SING-PD" trial (Singing In Groups for Parkinson's Disease) to investigate whether group singing can improve the decreased voice volume experienced by many PD patients, which can lead to distress, social embarrassment, and social isolation. The study will recruit Parkinson's patients who have difficulty with voice and speech. After 12 weeks of group singing therapy, the researchers will use sophisticated computerized speech analysis equipment to measure changes in their vocal capability.

The funding was awarded under the Foundation's Clinical Intervention Awards initiative, one of MJFF's three annually recurring Edmond J. Safra Core Programs for PD Research. The program supports novel or critical clinical intervention trials of promising therapeutic approaches that can significantly and fundamentally improve treatments for Parkinson's disease. Detailed information, including grant abstracts and researcher bios, is available on the Foundation's Web site.

The Michael J. Fox Foundation is dedicated to ensuring the development of better treatments, and ultimately a cure, for Parkinson's disease through an aggressively funded research agenda. MJFF has funded $157 million in research to date.

SOURCE Michael J. Fox Foundation
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