A new brain imaging clinical trial funded by the National Institutes of Health (NIH) has showed that multiple sclerosis drug ibudilast was better than a placebo at slowing down brain shrinkage.
Supported by the NIH’s National Institute of Neurological Disorders and Stroke (NINDS), the randomised trial compared budilast to placebo in a total of 255 progressive multiple sclerosis (MS) patients.
The study was conducted at 28 clinical sites over 96 weeks and monitored the decrease in brain atrophy progression or shrinkage. The patients were subjected to MRI brain scans every six months.
In order to evaluate differences in brain changes between the two groups, the investigators used multiple analysis techniques on the MRI images.
While both groups had brain atrophy, the rate was observed to be slower in patients administered with ibudilast than those given the placebo.
Patients who received placebo were found to experience an average of 2.5ml more brain shrinkage over the two year study.
NINDS director Walter Koroshetz said: “These findings provide a glimmer of hope for people with a form of multiple sclerosis that causes long-term disability but does not have many treatment options.”
Data did not reveal any significant differences between the multiple sclerosis drug and placebo groups in the proportion of patients with adverse effects.
The most common ibudilast-related side effects were gastrointestinal conditions, such as nausea and diarrhea, as well as headaches and depression.
Trial lead researcher Robert Fox said: “The trial’s results are very encouraging and point towards a potential new therapy to help people with progressive MS.
“It also increased our understanding of advanced imaging techniques, so that future studies may require a smaller number of patients followed over a shorter period of time.”
MediciNova supplied both the active drug and placebo for the trial. The company also contributed around 10% of the funding under a cooperative agreement with NINDS.