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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT06453668
Eligibility Criteria:
Key Inclusion Criteria:
* Male or female patients ≥ 18 to 80 years of age.
* Diagnosis of ALS by revised El Escorial Criteria, at study entry within 24 months of first symptoms.
* Patients on existing ALS treatment must have been on a stable dose for 28 days.
Key Exclusion Criteria:
* Patient with severe systemic infections, current or within the two weeks prior to randomization.
* Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.
* Use of other investigational products or treatment in another investigational drug study within 30 days of screening
* Pregnant or nursing (lactating) women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06453668
Study Brief:
Protocol Section:
NCT06453668