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 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT02794857
Eligibility Criteria:
Key Inclusion Criteria:
* Diagnosis of clinically possible, clinically probable (with or without laboratory support), or clinically definite ALS (using the revised El Escorial Criteria)
* Forced vital capacity greater than or equal to 65% of that predicted for age and height
* Onset of ALS-related weakness less than 3 years prior to first dose of study drug
* Plasma high sensitivity C-reactive protein (hs-CRP) concentration of greater than or equal to 0.113 mg/dL at pre-screening/screening
* Stable dose (greater than 30 days) of riluzole if undergoing treatment with this agent
* For females: Not be of childbearing potential or agree to use adequate birth control during the study
Key Exclusion Criteria:
* Life expectancy of less than 6 months
* Tracheotomy or be using ventilatory assistance, including Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)
* Active pulmonary disease
* Gastrostomy
* Stem cell therapy
* Immune modulator therapy or participation in studies of other agents within 12 weeks of pre-screening/screening
* Unstable medical condition other than ALS
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT02794857
Study Brief:
Protocol Section:
NCT02794857