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Searching for better treatments, including better management of symptoms and complementary/alternative approaches, for all forms of MS is a high priority for the National MS Society. Well-designed clinical trials are crucial to determining the safety and effectiveness of therapies for MS. The National MS Society is dedicated to this effort in several ways:

• by providing support to investigators conducting trials
• by funding parallel studies to understand how an experimental treatment may work
• by training young physicians to excel in the meticulous process of MS clinical trials through our Sylvia Lawry Physician Fellowship Program
• and by convening scientific work groups to develop new tools and consensus related to conducting MS clinical trials. We funded the development of quality of life measures specific to MS, and foster their use as “outcome” measures in clinical trials and other research.

Finding better treatments and a cure requires better understanding of the immune attack in MS  and the resulting injury to the central nervous system. For people who already live with disability caused by MS, a cure would mean stopping the immune attack and finding a way to reverse the damage to restore function.

Here are some ways that Society-funded research has propelled treatment breakthroughs:

• Interferons: Society-funded investigators were the first to conduct a major clinical trial of any form of interferon in MS.
• Copaxone: The Society supported pre-clinical tests of what is now Copaxone.
• Novantrone: Society-funded investigator was among the first to investigate the potential of Novantrone in rodents with MS-like disease.
• Tysabri: The significance of the integrin molecule, the study of which led to the development of Tysabri, was discovered as part of a Society-funded research fellowship.
• We also support research into rehabilitation techniques in efforts to speed recovery from acute attacks and find better ways to maximize physical and mental abilities to improve day to day living and working.

We’re feeding the therapy pipeline in many ways, including:

• Funding basic research to uncover new targets for stopping the immune attack and protecting and rebuilding the nervous system
• Funding preclinical research on, and clinical trials of, promising agents

• Identifying funding gaps and providing seed money to support industry-based drug development through Fast Forward.

• We provided seed money to launch a network of investigators who wanted to conduct clinical studies to improve care and investigate new therapies, including those of little or no interest to drug companies. The group, called MS-CORE, includes over 85 sites in the U.S. and Canada.

• To improve the quality of clinical trials, the National MS Society supports a training program designed to train physicians in the art and science of conducting clinical trials. Many go on to test new therapies for MS.
• The Society is also funding research into new MRI (magnetic resonance imaging) techniques and new technologies such as OCT (optical coherence tomography, a way to visualize the health of nerve fibers at the back of the eye) and low-contrast vision testing to better track the effects of new therapies on brain tissues and disease activity.

Read more about how the Society has propelled research progress.

Research on Treatments to Improve Symptoms

Although we are making great strides toward understanding the cause of MS and finding more effective treatments, people with the disease continue to face daily challenges while coping with its unpredictable effects and symptoms. An important aspect of the Society’s research program is the search for ways to improve symptom management, functional abilities, quality of life, and the treatment of relapses.

Recently funded research projects related to helping people manage their MS include:

• techniques for improving learning and memory for everyday activities
• studying the effects of a home-based aerobic exercise program
• a study following a group of individuals with very mild cognitive deficits to determine to what extent these deficits change or progress over time, and at what rate
• comparing the time and accuracy of performing specific physical movements in patients who first practice the movements by mentally visualizing the task, compared to others who perform the task without prior visualization
• Managing relapses: The administration of steroids is the most common treatment to help speed recovery from MS relapses. Seven MS centers in the New York City area are studying the safety and benefit of oral as compared to intravenous steroids in the management of acute attacks in MS. If oral steroids are found to be as effective and safe as when administered by the intravenous route, this study may lead to a major change in the practice of medicine related to treating MS exacerbations.
• Read more about Research in MS Rehabilitation.

Alternative/Complementary Approaches

The National MS Society recognizes that people with MS often turn to alternative/complementary therapies such as vitamins, herbs, movement and other approaches. Rather than dismiss these possible alternative therapies, we are interested in funding well-controlled studies that will investigate their possible therapeutic effects.

Here is a sampling of studies of complementary therapies that we’ve funded:

• Ginkgo biloba – a small study in people with MS and cognitive impairment, suggesting further testing of ginkgo to improve learning and memory was warranted 
• Ginseng –a pilot study of ginseng to treat MS fatigue 
• Vitamin D – studies in mice suggesting vitamin D can influence the immune attack, a study suggesting that higher vitamin D concentrations in the blood are associated with a lower risk of MS, and a large study currently underway is investigating whether increased sunlight exposure and consequent increased production of vitamin D reduces the risk of developing MS 
• Omega-3-fatty acids – a small study testing their impact on disease activity and quality of life
• Cannabis – and its derivatives are being tested for their impact on spasticity in a Society-supported clinical trial
• Exercise regimens – are being explored for their ability to improve symptoms such as spasticity and to protect nervous system tissue
  

Current trials the Society is Supporting

The Society is currently supporting over 20 projects testing MS therapies, for a total multi-year commitment of nearly $10 million. Current clinical trials the Society is supporting include:

• Emmanuelle Waubant, MD, PhD (University of California, San Francisco) is conducting a clinical trial to determine if an oral drug called riluzole can protect brain and spinal cord tissues in MS. A molecule called glutamate has been identified in MS brain lesions. Glutamate helps excite nerve cells. Some research suggests that too much glutamate may contribute to tissue damage in MS. Dr. Waubant and colleagues are testing the ability of riluzole to prevent the release of glutamate and, it is hoped, protect nerve fibers from damage in MS. The team is conducting a phase I/II trial in 40 patients recently diagnosed with relapsing-remitting MS. The team is investigating the safety of riluzole in MS and using MRI scanning to track disease activity and progression in the brain. This is among the first studies that tests a drug that may be protective for the nervous system in MS. Because riluzole is already approved by the U.S. FDA for treating ALS (Lou Gehrig’s disease), a successful result from this trial would likely lead to larger-scale, more definitive trials.

• Rhonda R. Voskuhl, MD (University of California at Los Angeles -- The Southern California Chapter of the National MS Society has pledged to raise the amount needed to see that this project is completed) and her team are testing whether a combination trial of Copaxone and the oral sex hormone estriol can slow disease course and activity in women with in relapsing-remitting MS. Estriol levels rise significantly during pregnancy, when most women’s MS disease activity declines. This led some to suspect that estriol may be responsible for this easing of symptoms during pregnancy. This two-year, controlled clinical trial involves 130 women being tested at seven centers for 2 years. The team is evaluating effects of the treatment combination on relapse rates and several clinical and magnetic resonance imaging measures of disability progression. If successful, this clinical trial will lay the groundwork for a larger, definitive trial that could lead to a new treatment option for women with MS. Its results may also have implications for women with other autoimmune diseases, such as rheumatoid arthritis.

Other recent clinical trials the National MS Society has supported include:

• A controlled trial of the ability of cannabis to treat MS spasticity, taking place at the University of California, Davis;

• A controlled trial of the ability of cannabis to treat MS spasticity, taking place at the University of California, Davis;

• a Phase I clinical trial at the University of California at Los Angeles to test safety and preliminary effectiveness of testosterone in men with relapsing MS;
• a comparison study of stimulants for MS-related fatigue and cognitive problems;
• phase I trials of several different experimental “peptide” therapies;
• a phase II clinical trial at the University of Southern California that tested T-cell vaccination in secondary-progressive MS;
• a phase II trial of rituxumab, an immune-based experimental therapy for relapsing-remitting MS;
• a trial at the University of Wisconsin testing whether eating the eggs of a harmless worm can alter immune activity in MS;
• a study tracking whether the steroid methylprednisolone can protect brain tissue integrity in MS.

Clinical Trials Activity in MS is Growing

We’ve been tracking clinical trials in MS for over 20 years. We had information about 46 trials in 1983; today there are at least 130 clinical trials worldwide that are testing new drugs, or combinations of therapies, and oral therapies on all forms of MS.