PCORI Awards $2 Million to Study Treatments for Fatigue in MS Patients

The Patient-Centered Outcomes Research Institute (PCORI) recently awarded a sum of $5.5 million to two researchers at the University of California, San Francisco (UCSF).

Bardia Nourbakhsh, MD. (Credit: UCSF)

Bardia Nourbakhsh, MD, a clinical fellow in Neurology, received a $2 million grant to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of several drugs in reducing fatigue — and improving the quality of life — in patients with multiple sclerosis (MS).

Fatigue is one of the most common symptoms of MS, occurring in about 80% of all patients. It can significantly interfere with a person’s ability to function at home and work. Fatigue also can be the most prominent symptom in a person who otherwise has minimal limitations.

Methylphenidate, amantadine and modafinil are often used to treat fatigue in MS patients, although the U.S. Food and Drug Administration (FDA) has not approved any of these drugs for this indication.

“We propose to perform a clinical trial to find out if any of the commonly used drugs is truly effective in reducing fatigue in diverse group of patients with MS, mirroring the real-world setting,” Nourbakhsh said in a UCSF news release.

As per trial protocol, each patient will be given the drugs at different times. Investigators will evaluate fatigue through phone or online questionnaires to minimize the burden on the participants.

The researchers will also examine how patients tolerate different dosages, and evaluate the drugs’ ability to reduce fatigue and improve life quality, while determining which type of patient

Margaret Fang, MD, MPH. (Credit: UCSF)

may benefit more from a specific treatment.

“Successful execution of our project will increase the attention of clinicians, patients, and policy maker to this common, disabling, undertreated, and under-researched MS symptom,” Nourbakhsh said.

Margaret Fang, MD, MPH, an associate professor of Medicine, was awarded $3.5 million for work that will compare the effectiveness of blood thinners for the long-term treatment of venous thromboembolism.

PCORI is an independent and nonprofit organization, based in Washington, D.C., authorized by Congress in 2010. Its mission is to improve the quality and relevance of evidence available so as to help patients, caregivers, clinicians, employers, insurers, and policymakers arrive at informed health decisions.