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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT05105958
Eligibility Criteria:
Inclusion Criteria:
* Possible, probable (clinically or laboratory supported) or definite ALS according to the revised version of the El Escorial criteria
* Disease duration \< 18 months
* Vital capacity of more than 60% of normal (defined as slow vital capacity, best of three measurements)
* Age more than 18 years
* On a stable dose of riluzole for at least four weeks or not taking riluzole
* On a stable dose of edaravone for at least four weeks or not taking edaravone
* Capable of thoroughly understanding all information given and giving full informed consent according to GCP
Exclusion Criteria:
* Previous participation in another clinical study within the preceding 12 weeks
* Proven SOD1- or FUS - mutation
* Tracheostomy or assisted ventilation of any type during the preceding three months
* Pregnancy or breast-feeding females
* Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
* Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
* Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
* Alcoholism
* Cardiovascular disorder/arrhythmia
* Impaired kidney function, defined as creatinine levels of 2.5 x upper limit of normal (ULN)
* Impaired liver function, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) of 3 x ULN
* Liable to be not cooperative or comply with trial requirements as assessed by the investigator, or unable to be reached in the case of emergency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05105958
Study Brief:
Protocol Section:
NCT05105958