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 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT07088159
Eligibility Criteria:
Inclusion Criteria:
* ALS diagnosis
* Age 18 -80 years at time of signing informed consent form
* Ineligible for other interventional ALS clinical research participation
* Vital Capacity less than 50% of predicted capacity for age, height, and sex
* If currently taking standard of care treatment for ALS, must be on stable dose for at least 30 days prior to taking SPG302.
* Life expectancy of at least 6 months, according to Investigator's judgement
Exclusion Criteria:
* Clinically significant and/or unstable medical condition (other than ALS) that would pose a risk to the patient
* Known ongoing or clinically uncontrolled cardiac disease
* Clinically significant liver disease
* Clinical significant cognitive impairment or neurological disorder, as determined by Investigator judgement
* Concomitant use of another investigational medical product for treatment of ALS
* Unable to reliably and regularly swallow whole oral medications on a daily basis
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07088159
Study Brief:
Protocol Section:
NCT07088159