NCT06441617 Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
| NCT ID | NCT06441617 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Accelerated Cure Project for Multiple Sclerosis |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2027-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,000 participants in total. It began in 2024-12-05 with a primary completion date of 2027-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Unwilling or unable to consent * Refusal to saving, processing and forwarding of pseudonymized data * Concurrent participation in another interventional trial
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06441617 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06441617 currently recruiting?
Yes, NCT06441617 is actively recruiting participants. Contact the research team at cafe-ms@iconquerms.org for enrollment information.
Where is the NCT06441617 trial being conducted?
This trial is being conducted at Washington D.C., United States, Baltimore, United States, Waltham, United States, Portland, United States and 2 additional locations.
Who is sponsoring the NCT06441617 clinical trial?
NCT06441617 is sponsored by Accelerated Cure Project for Multiple Sclerosis. The trial plans to enroll 2,000 participants.
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