Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Neurology, ALS |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/22/2019 |
| Start Date: | June 11, 2018 |
| End Date: | June 11, 2019 |
| Contact: | Sherri Anderson |
| Email: | sanderson10@kumc.edu |
| Phone: | 913-945-9936 |
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.
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.
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.
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.
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
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