Project Summary
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.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
About 400,000 Americans have MS. This health problem is one of the main causes of disability in young adults. MS affects the central nervous system and makes it hard for the brain to communicate with the rest of the body. As a result, people with MS may have fatigue, numbness, vision changes, bladder problems, and problems moving. Fatigue is one of the most common symptoms of MS; it can be disabling. Fatigue is also a major cause of patient unemployment and distress for many patients and their families. Little research has taken place on medicines to treat fatigue in patients with MS.
The US Food and Drug Administration hasn’t approved any medicines to treat fatigue in patients with MS. But doctors often use amantadine, modafinil, and methylphenidate to treat fatigue in such patients. These medicines have been approved to treat other health problems. This study looks at whether these three medicines lessen fatigue in patients with MS. Researchers also are looking at whether any of the medicines is better at treating fatigue than the others.
Who can this research help?
This research can help patients with MS and their doctors decide whether to use medicine to treat fatigue.
What is the research team doing?
The research team is working with 136 adults with MS who have fatigue. At different times, patients are taking each of the three medicines, as well as a placebo (a pill with no active ingredients). Patients start with one medicine and take it for six weeks. Patients then wait two weeks before taking another medicine for six weeks. Patients repeat this process until they have taken all three medicines and the placebo.
Different patients take the medicines in different orders. The research team wants to learn whether the order in which patients take the medicines makes a difference in the way patients feel while taking each of the different medicines. Changing the order for different patients helps the researchers understand if changes in fatigue are due to the medicine a patient is currently taking instead of due to medicines the patient took earlier.
Researchers follow up with patients about five weeks after they start taking each medicine. The research team uses a questionnaire to measure patients’ fatigue and find out how fatigue affects patients’ lives. Researchers are also trying to find out whether some medicines work better for some groups of patients. These groups of patients include those with progressive or relapsing-remitting forms of MS and those with higher or lower levels of disability.
The research team is seeking advice from patients and partners such as the National Multiple Sclerosis Society and experts in MS-related fatigue and research on how to design and carry out the study. Patients are suggesting ways to enroll others in the study. Other study partners are helping advertise the study and making sure doctors and patients know about study results.
Research methods at a glance
| Design Element | Description |
|---|---|
| Study Design | Randomized controlled trial |
| Population | Patients aged 18 years and older with multiple sclerosis (MS) and fatigue |
| Interventions/ Comparators |
|
| Outcomes |
Primary: fatigue’s effect on patients’ lives Secondary: quality of life, sleepiness |
 |
5-week follow-up for primary outcome for each medicine |
Journal Articles
Project Details
Partners
Patient/Caregiver Partners
Other Stakeholder Partners
^Bardia Nourbakhsh, MD, was affiliated with The Regents of the University of California when this project was initially awarded.