Actively Recruiting
Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
Led by Accelerated Cure Project for Multiple Sclerosis · Updated on 2026-04-15
2000
Participants Needed
6
Research Sites
144 weeks
Total Duration
On this page
Sponsors
A
Accelerated Cure Project for Multiple Sclerosis
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
CAFE-MS will assess the effectiveness of two online programs for fatigue in multiple sclerosis (MS). Although they differ, both of these online programs contain information about MS and fatigue intended to help people with MS understand and manage their fatigue. This large-scale, decentralized clinical trial is projected to enroll 2,000 people with MS. The collaboration between iConquerMS and 5 Veterans Affairs (VA) sites in the MS Centers of Excellence is designed to ensure sufficient representation of people with MS from populations traditionally under-represented in MS clinical trials. The study is a 3-arm, randomized controlled clinical trial with study participation lasting 1 year. Two of the trial arms will include one of two online programs for managing fatigue in MS added to the trial participants' usual MS treatment, and the third arm will include usual MS treatment alone. The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months. Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial.
CONDITIONS
Official Title
Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent by person with MS
- Living in the US
- Age 2 years or older
- Confirmed diagnosis of MS by a physician who is a neurologist or has a neurologist's diagnosis statement
- Fatigue Severity Scale score at or above eligibility threshold
- Fluent in English
- Willingness to self-administer an online intervention for 24 weeks and complete follow-up assessments
- Access to the internet and email with a compatible device (smartphone, computer, or tablet)
- No MS relapse or steroid treatment in the 4 weeks before screening (self-reported)
- No disease-modifying therapy started in the 4 weeks before screening (self-reported)
You will not qualify if you...
- Unwilling or unable to consent
- Refusal to allow saving, processing, and forwarding of pseudonymized data
- Concurrent participation in another interventional trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Washington VA Medical Center
Washington D.C., District of Columbia, United States, 20422
Actively Recruiting
2
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
iConquerMS
Waltham, Massachusetts, United States, 02451
Actively Recruiting
4
Portland VA Medical Center
Portland, Oregon, United States, 97239
Actively Recruiting
5
Nashville VA Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
6
Seattle VA Medical Center
Seattle, Washington, United States, 98108
Actively Recruiting
Research Team
G
Grace Okafor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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