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Quick Info
Currently Recruiting
Trial Type
Open Label, Non-Randomized, Parallel Assignment
Treatment Type
Drug: Ranolazine
Open label trial
Start Date
Contact Information
United States, Kansas
University of Kansas Medical Center, Kansas City, KS, 66160, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
Not specified
Months Since Onset
Number of months since first symptoms of ALS.
Not specified
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
Not more than 12 hrs/day
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
Not more than 12 hrs/day
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Open Label
Update Notes
Recruitment status updated
Contact info updated
Recruitment status updated
Trial details updated
Trial added

Other Information

The purpose of this research study is to evaluate the safety and effectiveness of Ranolazine, and how well it is tolerated in patients with Amyotrophic Lateral Sclerosis (ALS). Ranolazine is an FDA approved drug that is used for decreasing chest pain.
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
Amyotrophic Lateral Sclerosis (ALS) is a progressive debilitating and fatal neurodegenerative disease involving the motor neurons in the primary motor cortex, corticospinal tracts, brainstem and spinal cord with 5,000 newly diagnosed patients per year in the USA. There is a pressing need for additional therapies, as the only two FDA-approved drugs for ALS, riluzole and edaravone, showed prolongation of median survival of only two to three months and only a modest benefit in daily functioning, respectively. The ability to identify FDA approved drugs which can be repurposed to ALS, and which may slow disease progression, alleviate symptoms, or prolong survival will have an immediate positive impact of the lives of patients with ALS and their family members. Hypothesis: Ranolazine, an FDA approved drug for angina which inhibits the late Na+ current and intracellular Ca2+ accumulation may be neuroprotective in ALS by reducing neuronal hyperexcitability, may slow disease progression and reduce cramp frequency.
Trial Protocol as Published on
NCT03472950 (First Published: 3/1/2018)