NCT06441617Enrolling by invitation
Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 29 May 2024
- Start date
- 5 Dec 2024
- Primary completion date
- 15 Feb 2027
- Lead sponsor
- Accelerated Cure Project for Multiple Sclerosis
- Diseases
- Multiple sclerosis
- NCT number
- NCT06441617
What you commit to
- Study type: Interventional
- Planned participants: 2000
- From 5 Dec 2024 to the primary completion date, 15 Feb 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another interventional trial
Other
- Unwilling or unable to consent
- Refusal to saving, processing and forwarding of pseudonymized data
Who the study is looking for
- Informed consent by person with MS
- Living in the US
- Age ≥ 22
- Confirmed diagnosis of MS by a physician, who is a neurologist or has access to a neurologist's statement of diagnosis
- Fatigue Severity Scale score at or above eligibility threshold
- Fluent in English
- Willingness to engage in self-administration of an online intervention for 24 weeks and complete follow-up assessments
- Access to the internet and e-mail with a compatible device (smartphone, computer, or tablet)
- No MS relapse / no steroid treatment in the 4 weeks prior to answering the screening questionnaire (self-reported)
- No disease-modifying therapeutic (DMT) started in the 4 weeks prior to answering the screening questionnaire (self-reported)
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baltimore VA Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Nashville VA Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Portland VA Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Seattle VA Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| iConquerMS Coordinator of this site? Confirm its status | Waltham | United States | Unknown status |
| Washington VA Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.