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

NCT03127267 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2025-09-12

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

Interventions

DRUG

Masitinib (6.0)

Masitinib (titration to 6.0 mg/kg/day)

DRUG

Riluzole

Riluzole 50 mg tablet, treatment per os

DRUG

Placebo

treatment per os

DRUG

Masitinib (4.5)

Masitinib (titration to 4.5 mg/kg/day)

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Principal Investigators

  • Albert Ludolph, MD, PhD · Department of Neurology, University of Ulm, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Norway
  • Poland
  • Portugal
  • Russia
  • Serbia
  • Slovenia
  • Spain
  • Sweden
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03127267 on ClinicalTrials.gov