Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis

• Status: Unknown status
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center
• Collaborator: Gilead Sciences
• Treatments: Ranolazine

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