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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: Recruiting Phase 3 study of Amyotrophic Lateral Sclerosis, sponsored by AB Science.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 495 participants |
| Start Date | 2021-02-02 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
What NCT03127267 shows while recruiting
NCT03127267 is an interventional study that assigns participants to a tested intervention. The registered 495 participants enrollment target is mid-sized for trials with a published cap, below the 893-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (45% lower).
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03127267's enrollment target sits among peer trials
495 23rd of 102 higher than 80 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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