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Masitinib for ALS
Study Summary
This trial compares the effectiveness and safety of masitinib in combination with riluzole to a placebo combined with riluzole for treating ALS.
- ALS (Amyotrophic Lateral Sclerosis)
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Placebo & Riluzole
- Group 2: Masitinib (4.5) & Riluzole
- Group 3: Masitinib (6.0) & Riluzole
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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What portion of applicants met pre-screening criteria?
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