RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring

ASsessment Of RiLuzole To Reduce Paroxysmal Episodes of Atrial FIbrillatiON (The SOLUTION Study)

RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring (NCT05292209) is a Phase 2 interventional studying Atrial Fibrillation Paroxysmal, sponsored by University of Utah. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Atrial fibrillation (AF) is a growing clinical problem.1 AF is a highly dynamic condition involving episodes of sinus rhythm interspersed with periods of arrhythmia, becoming more difficult to terminate over time. AF carries a substantial cost, morbidity and mortality burden. There are two important approaches to the management of AF: 1). Controlling ventricular response rate without attempting to terminate or prevent AF (rate control), and 2). Attempting to control and maintain sinus rhythm (rhythm control).2 Current rhythm control with antiarrhythmic agents (AAD) is only moderately beneficial in restoration and maintenance of sinus rhythm but produce serious adverse events. AAD selection is limited based on the potential for pro-arrhythmia, patient's age, presence of structural heart disease, and renal or hepatic dysfunction. All AF anti-arrhythmic agents are associated with harm (number needed to harm 17-119).3 There remains an important need for development of an efficacious safe AAD for the control of AF. Recent published translational studies suggest that that neuronal-type Na+ channel blockade (nNav) with riluzole, a nNav inhibitor used to manage amyotrophic lateral sclerosis (ALS), can effectively suppress triggered atrial arrhythmias.4 In two independent retrospective cohorts, riluzole-treated ALS patients significantly lowered the incidence of new-onset AF. Riluzole is well-tolerated without evidence of pro-arrhythmia.5 Therefore, to assess riluzole's effects on the reduction of paroxysmal episodes of AF, we will conduct a prospective, randomized, placebo-controlled human study using holter monitors that offer continuous electrocardiographic monitoring pre- (1 month) and with exposure to riluzole or placebo (1 month) to determine statistically superior reductions in episodes of AF.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Atrial Fibrillation Paroxysmal and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 78 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Atrial Fibrillation Paroxysmal subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Males or Female adult patients (\> 18 years old) with a history of symptomatic AF documented electrocardiographically within \> 48 hours to 12 months before enrollment. - Is able to provide written willing to sign a consent form to participate in the study and is able to understand the procedures and study requirements. - Must voluntarily sign and date an willing to sign a consent form form that approved by the University of Utah IRB before the conduct of any study-specific procedure. - Will be anti-coagulated or is already anti-coagulated for planned cardioversion. - Is planned to undergo a cardioversion. - Patients who are not being treated with an anti-arrhythmic agent per their physician's treatment plan Who Should NOT Join This Trial: - Systolic BP \> 180 mmHg or Diastolic BP \> 100 mmHg; - Atrial Fibrillation due to electrolyte imbalance, hyperthyroidism, pericarditis, or other reversible illness; - NYHA FC IV Heart Failure (No ADHF Decompensation with 1 month); - Unstable Angina, AMI, coronary surgery within 3 or coronary angioplasty within 1 month of screening; - Wolff-Parkinson-White syndrome unless treated with successful ablation; - Infiltrative heart disease; - Severe valvular heart disease; - History of syncope or angina precipitated by an ventricular arrhythmia; - History of torsade de pointes; - Any polymorphic ventricular tachycardia; - Sustained monomorphic ventricular tachycardia, or cardia arrest; - Class I or III antiarrhythmic agents; - Females of childbearing age. If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) or is practicing 1 of the following medically acceptable methods of birth control for at least one full menstrual cycle prior to screening (see below), and agrees to continue with the regimen from the time of screening, throughout the entire study they are excluded; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Males or Female adult patients (\> 18 years old) with a history of symptomatic AF documented electrocardiographically within \> 48 hours to 12 months before enrollment. * Is able to provide written informed consent to participate in the study and is able to understand the procedures and study requirements. * Must voluntarily sign and date an informed consent form that approved by the University of Utah IRB before the conduct of any study-specific procedure. * Will be anti-coagulated or is already anti-coagulated for planned cardioversion. * Is planned to undergo a cardioversion. * Patients who are not being treated with an anti-arrhythmic agent per their physician's treatment plan Exclusion Criteria: * Systolic BP \> 180 mmHg or Diastolic BP \> 100 mmHg; * Atrial Fibrillation due to electrolyte imbalance, hyperthyroidism, pericarditis, or other reversible illness; * NYHA FC IV Heart Failure (No ADHF Decompensation with 1 month); * Unstable Angina, AMI, coronary surgery within 3 or coronary angioplasty within 1 month of screening; * Wolff-Parkinson-White syndrome unless treated with successful ablation; * Infiltrative heart disease; * Severe valvular heart disease; * History of syncope or angina precipitated by an ventricular arrhythmia; * History of torsade de pointes; * Any polymorphic ventricular tachycardia; * Sustained monomorphic ventricular tachycardia, or cardia arrest; * Class I or III antiarrhythmic agents; * Females of childbearing age. If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) or is practicing 1 of the following medically acceptable methods of birth control for at least one full menstrual cycle prior to screening (see below), and agrees to continue with the regimen from the time of screening, throughout the entire study they are excluded; * Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 3 full cycles (based on the subject's usual menstrual cycle period) before study medication administration * Total abstinence from sexual intercourse since the last menses before study medication administration * Intrauterine device * Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream); * Aminotransferases \> 5 x ULN (Test in the last 3 months); * CYP 1A2 Potent Inhibitors including cimetidine, ciprofloxacin, enoxacin, rifampin, barbiturates, and fluvoxamine; and * Active tobacco use. (i.e., smoking)

Treatments Being Tested

DRUG

Riluzole 50 MG

Riluzole 50mg tablets

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Utah

Salt Lake City, Utah, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05292209), the sponsor (University of Utah), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05292209 clinical trial studying?

Who can participate in NCT05292209?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05292209?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05292209. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05292209. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.