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 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT04172792
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Amyotrophic Lateral Sclerosis (ALS) according to the revised version of the El Escorial criteria (Ludolph et al. 2015)
* Slope of ALS Functional Rating Scale Revised (ALSFRS-R) of \>0.25 points per month at baseline visit based on the formula (48 - score at baseline visit) / (time between date of first symptom and baseline visit)
* stable on standard therapy riluzole (100 mg/day) for at least 4 weeks
* capable of thoroughly understanding all information given and giving full informed consent according to good clinical practice (GCP)
Exclusion Criteria:
* already taking any dietary supplements
* participation in another clinical trial within the preceding 8 weeks
* tracheostomy or assisted ventilation of any type which exceeds 23 hours per day
* pregnancy or breast-feeding females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04172792
Study Brief:
Protocol Section:
NCT04172792