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:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT04097158
Eligibility Criteria:
Inclusion Criteria:
1. Either possible, probable, or definite ALS, predominantly lower motor neuron disease, predominantly upper motor neuron disease, or bulbar
2. With or without cognitive involvement
3. Willing to participate
4. On no experimental treatment
5. Ages 18 - 85
6. No prior exposure to Edaravone (Radicava)
7. On a stable dose of Riluzole for 30 days or off Riluzole
8. Male or female
9. Females of childbearing age must use contraception
Exclusion Criteria:
1. Unstable medical illness
2. Abnormal liver function (\>2x ULN)
3. Unlikely to survive for 26 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04097158
Study Brief:
Protocol Section:
NCT04097158