What the trial was testing
The COMBO-MS enrolled 343 patients with multiple sclerosis. The study was sponsored by University of Michigan and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was long-term safety (phase 4). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
All three treatments reduced fatigue by about 30% in people with MS after 12 weeks.
The Lancet. Neurology · 2024 · NCT03621761
These findings — that talk therapy and modafinil each cut MS fatigue by roughly the same amount — were published in the The Lancet. Neurology and represent the headline result of the study.
Researchers tracked outcomes across 343 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with multiple sclerosis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
If you have MS and struggle with exhausting fatigue, this study shows you have real options. Talk therapy focused on fatigue helped just as much as the wakefulness pill modafinil — and both are FDA-approved for MS fatigue management. Taking both together didn't add extra benefit, so you and your doctor can choose whichever fits your life better.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open multiple sclerosis trials
Motor Imagery and Action Observation for Gait Function in MS
This study will investigate whether mentally simulating walking movements while watching others walk can improve walking performance in individuals with Multiple Sclerosis (MS). Participants will be divided into two groups: one group will watch walking videos and imagine themselves walking, while the other group will watch nature scenes. The study will measure muscle activity and walking patterns to assess the effects. The results may help support the use of mental practice techniques to improve mobility in people with MS.
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
This study is to identify the safety and efficacy of repeat IV(Intravenous) and IT(Intrathecal) administrations of UMSC01 in patients with MS. While anti-inflammatory drugs are routinely used for the treatment of MS by inhibiting immune responses, their effects on axon remyelination or neuroregeneration are limited. The combined systemic delivery of UCMSCs via intravenous injection and local administration of the cells by IT was to have safety and therapeutic efficacy for patients with MS.