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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03472950
• Date of registration: 01/03/2018
• Prospective Registration: Yes
• Primary sponsor: University of Kansas Medical Center
• Public title: Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis
• Scientific title: Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis
• Date of first enrolment: June 11, 2018
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03472950
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Jeffrey Statland, MD
• Affiliation: University of Kansas Medical Center

• Name: Sherri Anderson

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

ALS

Intervention(s)

Drug: Ranolazine 500 MG

Drug: Ranolazine 1000 MG

Primary Outcome(s)

Dose limiting toxicities (DLT) [Time Frame: Up to Week 12]

Secondary Outcome(s)

Cramp potential duration [Time Frame: Baseline, Weeks 2 and 6]

Cramp Questionnaire [Time Frame: Baseline, Weeks 2, 6, and 8]

Fasciculation frequency on muscle ultrasound [Time Frame: Baseline, Weeks 2 and 6]

Secondary ID(s)

STUDY00141491

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gilead Sciences