Testing online treatments for MS fatigue
Fatigue affects around 70% of people with MS — yet effective treatments remain scarce. Drug-based approaches have shown inconsistent results and often come with significant side effects. CAFE-MS is one of the largest clinical trials ever conducted to address this gap.
Funded by a $4.4 million grant from the Department of Defense Congressionally Directed Medical Research Programs, the Confirmatory Trial for Alleviating FatiguE in MS (CAFE-MS) is testing whether two online therapeutic programs can effectively reduce fatigue in people with MS. The trial is overseen by the U.S. Food and Drug Administration — meaning a successful outcome could lead directly to FDA approval of a new non-drug treatment option for MS fatigue.
Who is leading it
CAFE-MS is led by Dr. Stephanie Buxhoeveden, chief scientific officer at ACP, alongside Prof. Stefan Gold, professor of neuropsychiatry at Charité–Universitätsmedizin Berlin, one of Europe’s largest university medical centers. Additional partners include the U.S. Department of Veterans Affairs MS Centers of Excellence, GAIA AG, a global pioneer in evidence-based digital therapeutics, and Ordinal Data, Inc.
The trial aims to enroll 2,000 people with MS from 2024 to 2027, with particular outreach to people from minority communities and rural areas to ensure the findings reflect the full diversity of the MS population.
ACP’s role
ACP is the U.S. operational lead, driving participant recruitment through iConquerMS and ensuring the trial meets the inclusive enrollment standards required for findings to apply broadly.
Want to participate?
People with MS who experience fatigue may be eligible. Participants who complete all questionnaires receive up to $120 in compensation.