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  • Research & Results
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  • Comparing Three Medicines to Treat Fa...

This project has results

Comparing Three Medicines to Treat Fatigue in Patients with Multiple Sclerosis (MS) -- The TRIUMPHANT-MS Study

Sign Up for Updates to This Study  

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. In the meantime, results have been published in peer-reviewed journals, as listed below.

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
  • Amantadine
  • Modafinil
  • Methylphenidate
  • Placebo
Outcomes

Primary: fatigue’s effect on patients’ lives

Secondary: quality of life, sleepiness

Timeframe 5-week follow-up for primary outcome for each medicine

Journal Articles

Article Highlight: Fatigue is one of the most common problems among patients living with multiple sclerosis (MS). Three drugs—amantadine, modafinil, and methylphenidate—are commonly prescribed for reducing fatigue in patients with MS, but conclusive evidence for their effectiveness is lacking. As published in Lancet Neurology, this PCORI-funded study found that these three drugs were no more effective in reducing fatigue in a group of nearly 170 patients with MS than a placebo pill.

Results of This Project

Lancet Neurology

Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial

Related Articles

Contemporary Clinical Trials

Treatment of fatigue with methylphenidate, modafinil and amantadine in multiple sclerosis (TRIUMPHANT-MS): Study design for a pragmatic, randomized, double-blind, crossover clinical trial

Project Details

Principal Investigator
Bardia Nourbakhsh, MD
Project Status
In PCORI Peer-Review Process
Project Title
Randomized, Double-Blind, Crossover, Placebo-Controlled Trial of Amantadine, Modafinil, and Methylphenidate for Treatment of Fatigue in Multiple Sclerosis
Board Approval Date
July 2016
Project End Date
February 2021
Organization
Johns Hopkins University^
Year Awarded
2016
State
Maryland
Project Type
Research Project
Health Conditions  
Neurological Disorders
Multiple Sclerosis
Intervention Strategies
Drug Interventions
Populations
Individuals with Disabilities
Funding Announcement
Treatment of Multiple Sclerosis
Project Budget
$2,065,534
Study Registration Information
HSRP20164139
NCT03185065

Partners

Patient/Caregiver Partners

Rebecca Gemignani; National MS Society

Other Stakeholder Partners

Jennifer Graves MD, PhD

^Bardia Nourbakhsh, MD, was affiliated with The Regents of the University of California when this project was initially awarded.

Page Last Updated: 
December 15, 2020

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Meetings & Events

January 21
Cycle 1 2021 Broad PFA Applicant Town Hall
February 2
PCORI 2021 and Beyond: Opportunities for Funding and Involvement in Patient-Centered Research
February 9
Board of Governors Meeting: February 9, 2021

PCORI

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