What the trial was testing
The NOVA enrolled 585 patients with multiple sclerosis. The study was sponsored by Biogen and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. 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
Patients on the six-week schedule had about five times more new brain lesions than those on the monthly schedule.
The Lancet. Neurology · 2022 · NCT03689972
These findings — that patients on six-week dosing vs. monthly dosing — were published in the The Lancet. Neurology and represent the headline result of the study.
Researchers tracked outcomes across 585 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're on natalizumab for MS, this study suggests that spacing infusions to every six weeks instead of every four may lead to more disease activity. The six-week option is sometimes chosen to reduce the risk of a rare brain infection, but it may not control MS as well. Talk with your neurologist about the right schedule for you based on your individual risk factors. Natalizumab is FDA-approved for relapsing MS.
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.