The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have revised prescribing information for the oral MS therapy Gilenya® (fingolimod, Novartis). The recommendations were based on independent safety reviews initiated by the agencies after deaths had been reported among patients taking Gilenya. The revised prescribing information defines who should avoid using this MS therapy based on pre-existing medical conditions, and alters the recommended testing and heart monitoring that occurs when the first dose is given.
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National MS Society May 15, 2012
A small clinical trial by California investigators found some benefit of smoked marijuana against spasticity (muscle tightness and spasms) and pain in people with MS. Participants also experienced significantly reduced thinking ability after smoking marijuana, highlighting the need for research on cannabis products or other treatments that can more selectively reduce painful symptoms without producing adverse effects on cognitive function. Additional research examining the effects of marijuana on spasticity in MS is being supported by the National MS Society and others. The current study was published online on May 14, 2012 in the Canadian Medical Association Journal (CMAJ).
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National MS Society May 14, 2012
Disease progression, or gradual worsening, experienced by people who have multiple sclerosis usually occurs over many years, and it is difficult to track with the standard clinical measurement scales used by doctors to assess disease activity. An international meeting has convened to determine how to improve clinical measures so that MS progression can be better tracked, especially during clinical trials of experimental therapies aimed at stopping progression. Better ways of measuring changes in disability will help to speed the development of new therapies for MS, in particular for progressive forms of the disease.
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National MS Society May 11, 2012
Today the U.S. Food and Drug Administration released a safety communication to inform people with MS, doctors and others about potential risks associated with procedures and devices used to treat CCSVI (chronic cerebrospinal venous insufficiency). The communication from the FDA outlines these risks and encourages more research to provide better understanding of the relationship between CCSVI and MS and to guide possible treatment decisions by people with MS and their health care providers.
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National MS Society May 10, 2012
In Mouse Model, Halting An Enzyme Can Slow Multiple Sclerosis
Researchers studying multiple sclerosis (MS) have long been looking for the specific molecules in the body that cause lesions in myelin, the fatty, insulating cells that sheathe the nerves. Nearly a decade ago, a group at Mayo Clinic found a new enzyme, called Kallikrein 6, that is present in abundance in MS lesions and blood samples and is associated with inflammation and demyelination in other neurodegenerative diseases. In a study published this month in Brain Pathology, the same group found that an antibody that neutralizes Kallikrein 6 is capable of staving off MS in mice.
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Medical News Today May 2, 2012
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have revised prescribing information for the oral MS therapy Gilenya® (fingolimod, Novartis). The recommendations were based on independent safety reviews initiated by the agencies after deaths had been reported among patients taking Gilenya. The revised prescribing information defines who should avoid using this MS therapy based on pre-existing medical conditions, and alters the recommended testing and heart monitoring that occurs when the first dose is given.
To read this full article, click here.
National MS Society April 20, 2012
Investigators at several centers nationwide are recruiting 172 people with relapsing-remitting MS to compare the effectiveness of the current recommended amount of vitamin D supplementation versus high dose vitamin D supplementation at reducing MS disease activity, when added to standard therapy with glatiramer acetate (Copaxone®, Teva Pharmaceutical Industries). The principal investigator is Ellen Mowry, MD, MCR (John Hopkins University, Baltimore) and the study is funded by a research grant from the National MS Society.
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National MS Society April 19, 2012
The Canadian Institutes of Health Research (CIHR) announced that after a rigorous peer review process, a research team has been chosen to conduct a phase I/II clinical trial to determine the safety of venous angioplasty and obtain evidence on patient outcomes in people with MS. The CIHR has indicated that the names and location of the chosen Canadian team will be announced after the researchers obtain their required ethics approval from relevant institutional research ethics board(s).
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National MS Society April 18, 2012
People with multiple sclerosis often report worse symptoms when the weather is hot. A recent study concludes that hot weather may also worsen the ability to perform mental tasks in some people with MS. The research, which needs further exploration, may help people plan activities and may improve the design of future clinical trials. Victoria Leavitt, PhD, John DeLuca, PhD (Kessler Foundation Research Center, West Orange, NJ) and colleagues conducted the study with funding by the National MS Society and National Institutes of Health. The report was published early online March 7, 2012 in Neurology.
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National MS Society April 12, 2012
Investigators worldwide are recruiting 100 people with relapsing-remitting MS for a study testing the use of a prefilled syringe to administer monthly under the skin injections of the experimental therapy daclizumab high yield process (DAC HYP). Specifically, the study is looking at the immune response that is stimulated by this delivery method, and how the drug is absorbed in the body. This study – also called the OBSERVE study – is being sponsored by Biogen Idec and Abbott Biotherapeutics.
DAC HYP is being tested in another phase 3 study, the DECIDE trial, comparing DAC HYP to interferon beta-1a in 1800 people with MS.
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National MS Society April 2, 2012
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