A Study of Ranolazine in ALS

Launched by SWATHY CHANDRASHEKHAR, MBBS · Jul 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ranolazine to see how safe it is and how it may help people with Amyotrophic Lateral Sclerosis (ALS), a condition that affects muscle control. The trial will look at whether ranolazine can reduce muscle cramps, improve daily function, and enhance the quality of life for participants compared to a placebo (a harmless pill that doesn’t contain the active medication). They are currently recruiting participants aged 18 and older who have been diagnosed with ALS and are experiencing frequent muscle cramps, at least four times a week.

To be eligible for the study, participants should have a good ability to breathe, be able to swallow pills, and have been on a stable dose of any ALS medication for at least 30 days. Participants who have certain serious health issues or who are pregnant cannot join. If you decide to participate, you will receive either ranolazine or a placebo for a set period, and you’ll be monitored closely throughout the study. This is a chance to contribute to research that may help improve treatments for ALS in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years or older
• • Diagnosed with clinically definite, possible, probably, or lab-supported probable ALS per revised El Escorial criteria
• • Breathing assessment called forced vital capacity (FVC) greater than or equal to 50%.
• • Able to swallow pills at the start of the study and expected to for the length of the study.
• • If on ALS modifying medications must be on a stable dose at least 30 days.
• • Experiencing 4 or more cramps per week during a 2-week screening period.
• Exclusion Criteria:
• • Disease duration \< 5 years
• • Tracheostomy invasive ventilation, or noninvasive ventilation of more than 12 hours/day
• • Pregnant or lactating, adults unable to consent, and prisoners
• • Taking ranolazine or investigational drug or has received an investigational drug within 30 days (or 5 half-lives for drugs, whichever is longer) prior to screening
• • Medically uncontrolled comorbidities (heart, liver, kidney disease)
• • Baseline QTc interval prolongation \>450 ms for men/ \>470 ms for women, history of long QT syndrome, or medications which prolong the QT interval
• • Participation in an experimental drug trial less than 30 days before screening
• • Patients have to be on a stable dosage of any medications used to treat muscle cramps for ≥30 days or have been off these medications ≥30 days prior to randomization.