Amyotrophic Lateral Sclerosis study: Ranolazine
Official title A Study of Ranolazine in ALS
ClinicalTrials.gov ID: NCT06527222
What this study is testing
What is Ranolazine?
Ranolazine is an investigational oral medicine being studied as a potential treatment for amyotrophic lateral sclerosis (ALS). Ranolazine is designed to inhibit the late sodium current in cells, which may affect muscle function.
Also referred to as Ranexa.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if ranolazine is safe and whether it reduces cramps, improves function, and enhances quality of life in ALS patients.
- Who it's for
- Adults diagnosed with amyotrophic lateral sclerosis (ALS).
- What's involved
- Participants will be randomly assigned to take ranolazine or a placebo and will undergo regular check‑ups and questionnaires to monitor safety, cramps, daily function, and quality of life.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 28 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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)...
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Fairway, Kansas, United States
- Wichita, Kansas, United States
- Columbia, Missouri, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 28 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States; Jacksonville, Florida, United States; Fairway, Kansas, United States; Wichita, Kansas, United States; Columbia, Missouri, United States; Columbus, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.