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

NCT07174492 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2025-10-03

No results posted yet for this study

Summary

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).

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

Masitinib 4.5 mg/kg/day

Masitinib (titration to 4.5 mg/kg/day)

DRUG

Placebo

treatment per os

DRUG

Riluzole (100 mg)

Riluzole 50 mg tablet, treatment per os

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07174492 on ClinicalTrials.gov