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Tyrosine Kinase Inhibitor

Masitinib for ALS

Phase 3
Recruiting
Led By Albert Ludolph, MD, PhD
Research Sponsored by AB Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ALS disease duration from diagnosis no longer than 24 months at the screening visit
Patient treated with a stable dose of riluzole (100 mg/day) for at least 12 weeks days prior to the baseline visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

Study Summary

This trial compares the effectiveness and safety of masitinib in combination with riluzole to a placebo combined with riluzole for treating ALS.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with ALS for no more than 24 months.
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You have been taking the same dose of riluzole (100 mg/day) for at least 12 weeks before the study starts.
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You have been diagnosed with ALS using specific criteria from the World Federation of Neurology.
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You have familial or sporadic ALS (amyotrophic lateral sclerosis).
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Your ALS disease is getting worse at a certain speed, and this has been confirmed with a test over a 12-week period.
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You have specific scores on a test related to your condition, and you must meet certain score requirements to participate in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ALSFRS-R
Secondary outcome measures
ALSAQ-40
Change in the Combined Assessment of Function and Survival (CAFS) score from baseline to week 48
FVC
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Masitinib (6.0) & RiluzoleExperimental Treatment2 Interventions
Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment, followed by dose escalation to 6.0 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control. Masitinib will be administered as an add-on to riluzole at 50 mg b.i.d.
Group II: Masitinib (4.5) & RiluzoleExperimental Treatment2 Interventions
Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control. Masitinib will be administered as an add-on to riluzole at 50 mg b.i.d
Group III: Placebo & RiluzolePlacebo Group2 Interventions
Participants receive a matched dose placebo, given orally twice daily, in combination with riluzole at 50 mg b.i.d.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Riluzole
2006
Completed Phase 4
~2780
Masitinib (4.5)
2013
Completed Phase 3
~400

Find a Location

Who is running the clinical trial?

AB ScienceLead Sponsor
38 Previous Clinical Trials
15,227 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
394 Patients Enrolled for Amyotrophic Lateral Sclerosis
Albert Ludolph, MD, PhDPrincipal InvestigatorDepartment of Neurology, University of Ulm, Germany

Media Library

Masitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03127267 — Phase 3
Amyotrophic Lateral Sclerosis Research Study Groups: Placebo & Riluzole, Masitinib (4.5) & Riluzole, Masitinib (6.0) & Riluzole
Amyotrophic Lateral Sclerosis Clinical Trial 2023: Masitinib Highlights & Side Effects. Trial Name: NCT03127267 — Phase 3
Masitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03127267 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any age restrictions for participants in this experiment?

"In order to qualify for this clinical trial, patients must be aged between 18-81. There are 45 studies available for minors and 418 for elderly patients."

Answered by AI

Are there any other relevant investigations that have been done with Masitinib (4.5)?

"There are a total of 11 clinical trials being conducted to explore Masitinib's (4.5) efficacy. Of these 11 trials, 4 have progressed to Phase 3 testing. While the majority of trials for this treatment are based in Yekaterinburg and Gauteng, there are 94 locations across the world running experiments."

Answered by AI

Has the FDA cleared Masitinib (4.5) for public consumption?

"There is some evidence for efficacy and extensive safety data available from Phase 3 trials, so our team at Power gave Masitinib a score of 3."

Answered by AI

Are there any opportunities for people to participate in this trial?

"As of right now, this clinical trial is looking for patients who fit the given criteria. The original posting was on February 2nd 2021 with the most recent edit being on March 4th 2022."

Answered by AI

Who else is applying?

What site did they apply to?
University of Chicago Neurology
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
2021. "Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03127267.
~119 spots leftby Apr 2025
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