Trial Profile
A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 Trial to compare the efficacy and safety of masitinib in combination with standard of care versus placebo in combination with standard of care in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS)
Status:
Not yet recruiting
Phase of Trial:
Phase III
Latest Information Update: 10 Sep 2025
Price :
$35
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At a glance
- Drugs Masitinib (Primary) ; Riluzole
- Indications Amyotrophic lateral sclerosis
- Focus Registrational; Therapeutic Use
- Sponsors AB Science
Most Recent Events
- 24 Jul 2025 According to an AB science media release, the design has been validated in discussions with European health authorities, particularly with regard to the criteria for the optimal population selected for the confirmatory study: 1. Patients without rapid progression and 2. Patients without complete loss of function.
- 24 Jul 2025 According to an AB science media release, the authorization follows EMA's validation of the harmonized protocol, approved at the end of Step 1 of the CTIS procedure, and followed the authorization from the FDA. Consequently, AB Science can now initiate this registration study in Europe and the United States.
- 24 Jul 2025 According to an AB science media release, the confirmatory Phase 3 study with masitinib in amyotrophic lateral sclerosis (ALS), study AB23005, has been authorized by the first set of European countries (Spain, Greece, Slovenia) in Step 2 of the Clinical Trials Information System (CTIS) procedure. Professor Albert Ludolph, MD, PhD (University of Ulm, Germany), is the principal investigator of the study.