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 @ 10:18 PM
Ignite Modification Date:
2025-12-24 @ 10:18 PM
NCT ID:
NCT05053035
Eligibility Criteria:
Inclusion Criteria:
* Confirmation of C9orf72 mutation
* Diagnosis of ALS by revised El Escorial criteria
* Time since onset of muscle weakness due to ALS ≤36 months at the time of the Screening Visit
* Slow Vital Capacity (VC) ≥50% of predicted capacity at the time of the Screening Visit
* If taking riluzole, must be on a stable dose of riluzole for at least 30 days prior to the Screening Visit. Riluzole naive participants are allowed.
* If taking edaravone, must have completed at least one cycle of edaravone prior to the Screening Visit and plan to continue edaravone during the study. Edaravone naive participants are allowed.
* Females must not be pregnant, breastfeeding or planning to conceive within the study period. Males must agree to use acceptable contraception
* Capable of providing informed consent at the Screening visit and complying with study procedures throughout the study
Exclusion Criteria:
* Clinically significant, unstable, medical condition (other than ALS)
* Clinically significant heart disease, liver disease or kidney disease
* Cognitive impairment or dementia
* Current uncontrolled hypertension
* History of unresolved cancer
* Any experimental gene therapy
* Any experimental vaccine (any vaccine against COVID-19 either approved or administered under an Emergency Use Authorization is allowed)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05053035
Study Brief:
Protocol Section:
NCT05053035