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

ALS Clinical Trial

Official title: Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• ALS
• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

• NCT number: NCT03472950
• Study type: Interventional
• Source: University of Kansas Medical Center
• Contact: Sherri Anderson
• Phone: 913-945-9936
• Email: sanderson10@kumc.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: June 11, 2018
• Completion date: November 1, 2019