Project Summary

*This project was terminated due to issues relating to study recruitment.

PCORI has identified multiple sclerosis (MS) as an important research topic. Patients, clinicians, and others want to learn how different treatment strategies, aimed at changing specific symptoms or the overall course of MS, affect patients’ symptoms and quality of life. To address this issue, PCORI launched a funding initiative in 2015 on Treatment of Multiple Sclerosis. This research project is one of the studies PCORI awarded as part this program.

What is the research about?

About 400,000 Americans have MS. It affects the central nervous system and can cause fatigue, numbness, and vision, bladder, and mobility problems. Relapsing-remitting MS is the most common type of MS. Patients with this type of MS experience clearly defined attacks with new or increasingly strong symptoms, like numbness and mobility problems, followed by periods in which symptoms become less troubling. Doctors prescribe oral medicines (such as fingolimod and dimethyl fumarate) to help patients with relapsing-remitting MS. Doctors and patients do not know how fingolimod and dimethyl fumarate compare at preventing relapses, brain damage, and long-term disability and improving quality of life. This study examines the benefits and harms of these two medicines from the patient point of view.

Who can this research help?

This research can help adult patients and their doctors decide which oral medicine to use for relapsing-remitting MS.

What is the research team doing?

The research team is recruiting 1,360 adults ages 18 and older who have relapsing-remitting MS. Each participant has either just been diagnosed with MS or has already tried another medicine. Before participating, each patient’s doctor must determine that it is safe for that patient to take either of fingolimod or dimethyl fumarate. Half of the people in the study receive fingolimod, and half receive dimethyl fumarate. The researchers follow up after 24 months to find out, from both the patient’s point of view and their doctor’s assessment, how the medicines compare at preventing relapses and brain damage, reducing symptoms, and improving quality of life.

The research team is getting input on the study from patients, caregivers, nurses, psychologists, health policy makers, engineers, researcher experts in the neurosciences, and neurologist experts in patient-reported outcomes.

 Research methods at a glance

Design Element Description
Study Design Randomized controlled trial
Population Adults age 18 and older with relapsing-remitting multiple sclerosis
Interventions/
Comparators
  • Fingolimod
  • Dimethyl fumarate
Outcomes

Primary: patient overall disease experience

Secondary: no evidence of disease activity (no relapse, no new lesions, and no disability), fatigue, cognition, quality of life, psychiatric symptoms, biomarkers

Timeframe 24-month follow-up for primary outcome

Project Information

Renato Mantegazza, MD^
Fondazione IRCCS Istituto Neurologico "Carlo Besta" (Italy)
$3,408,294

Key Dates

61 months
July 2016
October 2019
2016

Study Registration Information

^Silvia Rossi, MD, PhD was the original Principal Investigator on this project.

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PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders.

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PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care.

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Last updated: February 20, 2020