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Disappointing Results Announced From Trial of Gilenya for Primary-Progressive MS

December 1, 2014

Preliminary results from a large, Phase III clinical trial of Gilenya® (fingolimod, Novartis), an oral therapy approved for treating relapsing forms of MS, suggest that the trial did not slow MS worsening over three years in people with primary-progressive MS.  The trial involved 970 people across 18 countries who took either fingolimod or an inactive placebo. According to a Novartis press release, the study did not show a significant difference between the groups on a combination of disability measures.  Further analysis, which is ongoing, may shed light on future trials involving people with primary-progressive MS, for which there are no approved disease-modifying medications.

“These preliminary results are disappointing,” commented Dr. Timothy Coetzee, Chief Advocacy, Services and Research Officer for the National Multiple Sclerosis Society.  “Hopefully a thorough analysis of the full data from this study will offer insights both for new approaches to treating progressive MS and for improving future trial designs,” he added.

Additional large-scale trials in people with progressive MS are ongoing. The National MS Society is pursuing all promising research paths and collaborating worldwide to drive progress in research in progressive MS, and is a collaborative leader in the International Progressive MS Alliance.

Read more about research on progressive MS

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.


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