Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
ConditionAmyotrophic Lateral Sclerosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-81
SponsorAB Science
About this trial
The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Masitinib (6.0)
- Riluzole
- Placebo
- Masitinib (4.5)
Treatment groups
495 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov