Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT07174492
Eligibility Criteria:
Inclusion Criteria:
1. The patient must have been diagnosed with clinically probable or definite ALS based on the World Federation of Neurology Revised El Escorial criteria.
2. Patients aged 18 to 80 years old and who have either familial or sporadic ALS.
3. Patients must have been treated with a stable dose of Riluzole (100 mg/day) for at least 30 days before the entering the trial.
4. If they are taking it, patients must have been on a stable dose for at least 30 days before study entry;
5. Patients should have experienced the first symptom of ALS no longer than 36 months before the screening visit
6. Disease Progression Rate: The ALSFRS-R progression rate (measured between onset and screening) should be between 0.3 and 1.1 point/month
7. ALSFRS-R Total Score: At screening and baseline, patients need to meet the following criteria:
Item #3: At least 3 points. Item #12: At least 2 points. Other Items: At least 1 point on each of the remaining 10 items
8. Contraception: Female patients of childbearing potential and male patients must use a highly effective method of contraception during the trial and for a specified period afterwards
Exclusion Criteria:
1. Patients should not have any significant neurological, psychiatric, systemic or organic disease that could interfere with the trial
2. Hypersensitivity to masitinib excipients or riluzole
3. Lung function: patients with an FVC (forced vital capacity) of less than 70% of the predicted normal value for their gender, height, and age are excluded
4. Patients with a weight less than 41 kg and a BMI (body mass index) less than 18 or greater than 35 kg/m² are not eligible.
5. Pregnant or nursing female patients at screening and baseline are excluded
6. Patients with pre-existing conditions that may be aggravated with the use of masitinib (severe skin toxicities or reactions, liver disorders, severe renal impairment, viral infections, cancer, severe cardiovascular disease, high risk of heart attack and/or stroke).
7. Patient treated concomitantly with medications that may interact with masitinib
8. Participants with a significant pulmonary disorder not attributed to ALS or who require treatments that might complicate the evaluation of the effect of ALS on respiratory function
9. Previous treatment with masitinib
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07174492
Study Brief:
Protocol Section:
NCT07174492