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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT05949294
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of ALS based on source-verifiable medical record and meets the Gold Coast Criteria
* Pathogenic or likely pathogenic SOD1 mutation based on source-verifiable medical records or genetic testing during Screening
* Slow Vital Capacity (SVC) ≥ 50% of predicted value adjusted for sex, age, and height (from a sitting position) at Screening
* Body Mass Index (BMI) ≥ 18.0 kg/m2 at Screening
* Able to complete at least 6 months of follow-up
* If taking any medication or supplement to treat ALS or ALS symptoms, must be on stable dose for ≥ 4 weeks prior to Day 1 and expected to remain at that dose until final study visit and not expected to start these medications after the first dose of ARO-SOD1
* Able and willing to provide written informed consent and to comply with all study assessments
* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of study or last dose of study drug, whichever is later. Males must not donate sperm and females must not donate eggs during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later.
Exclusion Criteria:
* Current or anticipated need of a diaphragm pacing system (DPS) during the study
* Participants using tofersen can be enrolled only after a washout period of approximately 20 weeks from the last tofersen dose to the first planned dose of ARO-SOD1
* History of having received stem cell therapy for ALS treatment
* Any current or anticipated contraindications to lumbar puncture (LP)
* The presence of an implanted shunt for drainage of CSF or an implanted central nervous system (CNS) catheter
* Human immunodeficiency virus (HIV), seropositive for hepatitis B virus (HBV), seropositive for hepatitis C virus (HCV)
* Uncontrolled hypertension
* Severe cardiovascular disease
* History of drug abuse or alcoholism within 6 months of study enrollment
* Inability to comply with study requirements
Note: additional inclusion/exclusion criteria may apply per protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05949294
Study Brief:
Protocol Section:
NCT05949294