Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis

Launched by AB SCIENCE · Jun 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called masitinib to see if it can help people with progressive multiple sclerosis (MS), specifically those with primary progressive or non-active secondary progressive MS. The goal is to find out if masitinib is effective and safe compared to a placebo (a harmless pill that looks like the real drug) in treating patients who have not had a relapse for at least two years. The trial is currently looking for participants aged between 65 and 74 who have had MS symptoms for at least five years and have a specific level of disability measured by the Expanded Disability Status Scale (EDSS).

To join the trial, participants must have an EDSS score between 3.0 and 6.0 and have shown a steady progression of their condition without improvement over the last two years. They should not have any other diseases that could explain their symptoms or MRI findings, and they must be able to undergo an MRI scan. Participants will take the medication or placebo for a set period and will be monitored for safety and effectiveness. This trial is important because it may help us learn more about new treatment options for people living with progressive MS.

Gender

ALL

Eligibility criteria

• Main inclusion criteria include:
• • Patients with either primary progressive or secondary progressive multiple sclerosis with onset of symptoms at least five years before baseline and with no relapse diagnosed according to the 2017 revised McDonald's criteria at least two years before screening
• • Patients with Expanded Disability Status Scale (EDSS) score between 3.0 to 6.0 (both inclusive) at screening and baseline
• • Patients with an EDSS score progression ≥1 point with no improvement during 2 years
• • Absence of T1 Gadolinium-enhancing brain lesions as measured by MRI at screening
• Main exclusion criteria include:
• • Patients suffering from a disease other than MS that would better explain the patient's neurological clinical signs and symptoms and/or MRI lesions observed at screening
• • Inability to complete screening MRI (contraindications for MRI) and/or any known allergy or hypersensitivity or any contra-indication to gadolinium macrocyclic
• • Patients treated with other disease modifying treatments in the time frames and conditions mentioned under previous treatment wash out period, assessed at baseline
• • Patients with lymphocytes \<1.0 × 10\^9/L at screening and at baseline