MediciNova is set to begin a clinical trial of MN-166 (ibudilast) to treat patients with amyotrophic lateral sclerosis (ALS), following the approval from the US Food and Drug Administration (FDA).
The randomized, double-blind, placebo-controlled trial is divided into two treatment arms, MN-166 and matching placebo, and includes a six-month treatment period followed by a six-month open-label extension.
The randomization will occur in a 2:1 ratio (MN-166: placebo) and the trial will see enrollment of around 60 male and female patients aged between 18 and 80 years.
According to the company, 40 subjects will take part in the MN-166 group, while the remaining 20 in the placebo group.
Carolinas HealthCare System Neurosciences Institute in Charlotte director of Carolinas Neuromuscular/ALS-MDA Center Dr Benjamin Rix Brooks is the principal investigator of the trial, which is funded by both the parties.
The trial is designed to evaluate several efficacy endpoints including functional activity (ALSFRS-R), respiratory function, muscle strength, and non-invasive ventilation (NIV) utilisation of MN-166.