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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
Pivotal Trial
Summary
This trial tests if a new medication taken with riluzole can help ALS patients by reducing inflammation and protecting nerve cells. ALS patients are targeted because current treatments are not very effective.
Eligible Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Amyotrophic Lateral Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
ALSFRS-R
Secondary study objectives
ALSAQ-40
Change in the Combined Assessment of Function and Survival (CAFS) score from baseline to week 48
FVC
+2 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with ALS for no more than 24 months.You have been taking the same dose of riluzole (100 mg/day) for at least 12 weeks before the study starts.Your lung function is less than 60% of what is expected for someone of your gender, height, and age.You have been diagnosed with ALS using specific criteria from the World Federation of Neurology.You have familial or sporadic ALS (amyotrophic lateral sclerosis).Your ALS disease is getting worse at a certain speed, and this has been confirmed with a test over a 12-week period.You have specific scores on a test related to your condition, and you must meet certain score requirements to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo & Riluzole
- Group 2: Masitinib (4.5) & Riluzole
- Group 3: Masitinib (6.0) & Riluzole
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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