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Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis

NCT06441617 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Online Program for Fatigue

An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • United States Department of Defense

    collaborator FED

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University Medical Center Goettingen

    collaborator OTHER

  • US Department of Veterans Affairs

    collaborator FED

  • Accelerated Cure Project for Multiple Sclerosis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-05
Primary Completion
2027-02-15
Completion
2027-09-14

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06441617 on ClinicalTrials.gov