Status:
COMPLETED
Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
Gilead Sciences
Conditions:
ALS
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ap...
Detailed Description
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 spina...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03472950
Start Date
June 11 2018
End Date
December 9 2022
Last Update
December 9 2024
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160