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$38 Million for 5 New MS Research Studies Announced by PCORI

September 12, 2017

– Studies will give people evidence to help them choose therapies

The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved more than $38 million to fund five studies comparing the effectiveness of different strategies for treating multiple sclerosis or its symptoms. 
Two studies will compare the outcomes between aggressive versus gradual approach to treating people who are newly diagnosed with relapsing MS. Another will research the use of exercise to increase mobility. Two others will investigate programs and therapies to manage MS fatigue. The studies incorporate ways to deliver programs and monitor benefits remotely so that people may benefit without leaving their homes.
“These large-scale research awards should have powerful impact for people with MS by answering critical real-world questions about treatment strategies and their effectiveness,” commented Bruce Bebo, PhD, Executive Vice President, Research, at the National MS Society. “We’re proud that the National MS Society provided early career training to four of these investigators, who have become leaders in efforts to stop MS and reverse its symptoms,” he added. 
"This research will help patients and clinicians address some of the difficult questions that arise with a disease that has a wide variety of symptoms, such as fatigue, pain, loss of vision and loss of coordination,” said PCORI Executive Director Joe Selby, MD, MPH. “As is the case with all our work, input from patients, clinicians and other stakeholders was essential to the process of identifying the research questions and health outcomes that these studies will address.”  
The new studies address evidence gaps and questions that people with MS and other healthcare stakeholders identified as their top priorities through PCORI’s process for topic selection. The five awards include:
  • A $13.5 million study based at Johns Hopkins University comparing two treatment options for people newly diagnosed with the relapsing-remitting form of MS. One option is an escalation approach, in which patients start taking a less-powerful drug with the option of switching to a more-potent therapy if the initial drug is not adequate. The other approach involves starting with a stronger drug that is potentially more effective, but also carries greater risk for significant adverse effects.
  • A $10.6 million project led by the Cleveland Clinic that will also compare the escalation strategy with the more-aggressive approach. This study will monitor patient-reported outcomes and use magnetic resonance imaging to measure changes in patients’ brain volume, a predictor of long-term disability that people with MS and their families consider very important.
  • A $5.7 million study based at the Shepherd Center in Atlanta that will evaluate the effectiveness of different types of exercise programs for people with MS. Decreased mobility is a common symptom of the disease, and it can lead to less physical activity. This project will compare exercise programs provided at gyms or rehabilitation facilities with a telerehabilitation program available to patients at home.
  • A $4.9 million project based at Case Western Reserve University that will compare three modes for delivering a course on fatigue-management strategies. Around 90 percent of people with MS experience fatigue. One strategy involves in-person instruction in the management strategies course during medical visits, and the two others involve delivery of the course via telehealth formats—teleconference or internet—to patients in their homes.
  • A $3.5 million study led by the University of Michigan that also focuses on treating fatigue. This study will compare the effectiveness of cognitive behavioral therapy versus use of the wakefulness-promoting drug modafinil. The study will also assess a combination of both therapies. Some of each patient’s information will be collected through a wrist-worn device that measures activity. 
With these latest awards, PCORI has invested $64 million to fund 12 comparative clinical effectiveness research (CER) studies related to MS. 
All of the awards are approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

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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