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NCT03127267 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Amyotrophic Lateral Sclerosis, sponsored by AB Science.

Recruiting
Registry status
Phase 3
Development phase
495
Enrollment target
20
Study locations

NCT03127267 is a Phase 3 study of Amyotrophic Lateral Sclerosis that is actively recruiting participants, run by AB Science. The registered enrollment target is 495 participants, below the 893-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT03127267, a Phase 3 study of Amyotrophic Lateral Sclerosis, is actively recruiting participants, sponsored by AB Science.

RECRUITING
Registry status
Phase 3
Development phase
495 participants
Enrollment target
20
Study locations

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 Studied

Amyotrophic Lateral Sclerosis

Interventions

  • DRUG Placebo
  • DRUG Masitinib (6.0)
  • DRUG Riluzole
  • DRUG Masitinib (4.5)

Study Locations (20)

Other

  • University Hospital Leuven (UZ Leuven) - Leuven
  • Bispebjerg Hospital - Copenhagen
  • CHU de Angers - Angers
  • Groupe Hospitalier Pellegrin Tripode - Bordeaux
  • Hôpital neurologique Pierre Wertheimer - Bron
  • CHU Gabriel Montpied - Clermont-Ferrand
  • CHU de Lille - Hopital Roger Salengro - Lille
  • CHU de Limoges - Hôpital Dupuytren - Limoges
  • CHU de Marseille - Hôpital de la Timone - Marseille
  • CHRU de Montpellier - Gui de Chauliac - Montpellier
  • CHU de Nancy - Hopital Central - Nancy
  • CHU Hôpital Pasteur Nice - Nice
  • CHRU de Tours - Hopital Bretonneau - Tours
  • Department of Neurology, University of Ulm - Ulm

Alabama

  • University of Alabama at Birmingham - Birmingham

California

  • University of Southern California - Los Angeles

Kentucky

  • University of Kentucky - Lexington

Maryland

  • Johns Hopkins Medicine Brain Science Institute - Baltimore

Massachusetts

  • Lahey Hospital and Medical Center - Burlington

Virginia

  • University of Virginia Health System - Charlottesville

Trial Details

FieldValue
Enrollment Target 495 participants
Start Date 2021-02-02
Est. Completion 2027-12
Phase Phase 3

Sponsor

AB Science

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03127267

The ClinicalTrials.gov registry entry for NCT03127267 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 495 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 893-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (45% lower). The listed sponsor is AB Science, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT03127267 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT03127267 about?

NCT03127267 is a clinical study titled "Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients". 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).

What is the current status of trial NCT03127267?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 495 participants. The study started on 2021-02-02. Estimated completion is 2027-12.

What conditions does trial NCT03127267 study?

This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.

What interventions are being tested in trial NCT03127267?

The interventions under investigation include: Placebo (DRUG), Masitinib (6.0) (DRUG), Riluzole (DRUG), Masitinib (4.5) (DRUG).

Who is sponsoring clinical trial NCT03127267?

This trial is sponsored by AB Science, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03127267 being conducted?

This trial has 20 study locations across Alabama, California, Kentucky, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.