Masitinib for ALS
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial requires participants to be on a stable dose of riluzole (100 mg/day) for at least 12 weeks before starting. The protocol does not specify if you need to stop other medications, so it's best to discuss with the trial team.
What data supports the effectiveness of the drug masitinib for ALS?
Is masitinib safe for humans?
How does the drug Masitinib for ALS differ from other treatments?
Masitinib is unique for ALS treatment because it is a tyrosine kinase inhibitor, which means it blocks certain enzymes that promote inflammation and cell growth, potentially slowing disease progression. This mechanism is different from Riluzole, the standard ALS treatment, which works by reducing damage to motor neurons.7891011
What is the purpose of this trial?
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.
Research Team
Albert Ludolph, MD, PhD
Principal Investigator
Department of Neurology, University of Ulm, Germany
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive masitinib or placebo in combination with riluzole, with dose escalation for masitinib over 48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are assessed for progression-free survival up to 36 months
Treatment Details
Interventions
- Masitinib
- Placebo
- Riluzole
Masitinib is already approved in European Union, United States for the following indications:
- Mast cell tumors in dogs
- Mast cell tumors in dogs
Find a Clinic Near You
Who Is Running the Clinical Trial?
AB Science
Lead Sponsor