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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT03472950
Eligibility Criteria:
Inclusion Criteria:
* Patients with clinically definite, probable, laboratory supported probable, or possible ALS per revised El Escorial criteria
* Cramp frequency greater than 4 cramps per week during 2 week run in
* ALS functional rating scale-revised (ALSFRS-R) score of greater than 24
* Able to lie on back for study procedures
Exclusion Criteria:
* Tracheostomy invasive ventilation, or use of non-invasive ventilation greater than 12 hours per day
* Pregnant or lactating
* Participation in a prior experimental drug trial less than 30 days prior to screening
* Patients taking ranolazine
* Patients taking medications which are contraindicated for use with ranolazine such as strong CYP3 inhibitors (ketoconazole, clarithromycin, nelfinavir), and CYP3 inducers (rifampin, phenobarbital)
* Patients with clinically significant medical comorbidities (hepatic, renal, cardiac, etc)
* Patients with baseline QT interval prolongation on Electrocardiography (ECG)
* Patients pre-disposed to secondary QT prolongation for other health conditions like family history of congenital long QT syndrome, heart failure, bradycardia, or cardiomyopathies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03472950
Study Brief:
Protocol Section:
NCT03472950