NCT06441617

Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Accelerated Cure Project for Multiple Sclerosis · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

• Multiple Sclerosis
• Fatigue

Interventions

Type	Name	Description
DEVICE	Online Program for Fatigue	An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.

Timeline

• Start date: 2024-12-05
• Primary completion: 2027-02-15
• Completion: 2027-09-14
• First posted: 2024-06-04
• Last updated: 2026-04-15

Locations

6 sites across 1 country: United States