Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

Launched by AB SCIENCE · Apr 20, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called masitinib, when combined with another drug called riluzole, in treating patients with Amyotrophic Lateral Sclerosis (ALS). The goal is to see if masitinib can help improve symptoms or slow down the progression of ALS compared to a placebo (a substance with no active medicine) also combined with riluzole. The trial is currently recruiting participants aged 65 to 74, and it is open to all genders.

To be eligible for this trial, patients must have a confirmed diagnosis of ALS and have been experiencing symptoms for no more than 24 months. They should also be taking a steady dose of riluzole for at least 12 weeks prior to joining the study and meet certain health criteria related to their ALS symptoms. Participants can expect to receive either the masitinib treatment or a placebo for a set period while continuing their riluzole therapy, and their progress will be closely monitored throughout the trial. It's essential to note that individuals with certain health conditions, such as severe respiratory issues or significant mental health problems, will not be able to participate.

Gender

ALL

Eligibility criteria

• Main inclusion criteria include:
• • Patients diagnosed with laboratory supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria
• • Patient with a familial or sporadic ALS
• • ALS disease duration from diagnosis no longer than 24 months at the screening visit
• • Patient treated with a stable dose of riluzole (100 mg/day) for at least 12 weeks days prior to the baseline visit
• • Patient with an ALSFRS-R score progression between onset of the disease and screening of \> 0.3 per month, confirmed with an ALSFRS-R score progression of ≥ 1 point during a 12-week run-in period between screening and randomization.
• • Patient with a score, at screening, of at least 26 overall, including a score of at least 3 on item #3 and at least 2 on each of the 12 ALSFRS-R individual component items and with a score, at randomization, of at least 2 on each of the 12 ALSFRS-R individual component items
• Main exclusion criteria include:
• • Patient with dementia or significant neurological, psychiatric, systemic or organic disease, uncontrolled or that may interfere with the conduct of the trial or its results
• • Patient with a FVC \< 60% predicted normal value for gender, height, and age at screening and baseline
• • Pregnant, or nursing female patient