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
Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?
The investigators hypothesize that hypogammaglobulinemia (defined as IgG serum concentration \<7.0g/L) is a treatable cause of fatigue in people with MS: The primary objective is to prove the link between hypogammaglobulinemia and fatigue in patients with multiple sclerosis. The secondary objective is to show that fatigue is mediated via frequent infections in people with MS and hypogammaglobulinemia.
Motor Learning of Fall Resistant Skills Through Slip and Trip Exposure in Multiple Sclerosis
The primary purpose of this interventional study is to examine the overall motor learning capacity from exposure to repeated perturbations among ambulatory people with multiple sclerosis (MS). This project will advance our understanding of learning new motor skills from exposure to external perturbations. If it is proven that people with MS can learn motor skills from perturbation training, the findings from this study will pave a theoretical foundation for applying perturbation training as a promising fall prevention intervention for people with MS.