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Neuronal-type Na+ channel blocker

Riluzole for Atrial Fibrillation (SOLUTION Trial)

Phase 2
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Will be anti-coagulated or is already anti-coagulated for planned cardioversion
Males or Female adult patients (> 18 years old) with a history of symptomatic AF documented electrocardiographically within > 48 hours to 12 months before enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

SOLUTION Trial Summary

This trial will study whether or not riluzole, a drug used to manage amyotrophic lateral sclerosis (ALS), can effectively suppress triggered atrial arrhythmias in people with atrial fibrillation (AF).

Who is the study for?
Adults over 18 with documented symptomatic Atrial Fibrillation (AF) not currently on anti-arrhythmic drugs, able to consent and follow study procedures. Excludes those with severe heart issues, certain arrhythmias, high liver enzymes, or using specific contraceptives or medications that interact with the trial drug.Check my eligibility
What is being tested?
The trial is testing Riluzole's ability to control AF by blocking certain sodium channels in nerves. It's a randomized study comparing Riluzole against a placebo using continuous heart monitoring before and during treatment for one month each.See study design
What are the potential side effects?
Riluzole is generally well-tolerated but can cause side effects like dizziness, gastrointestinal disturbances, elevated liver enzymes, weakness or fatigue. It does not typically cause pro-arrhythmia.

SOLUTION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking or will take blood thinners for a heart rhythm correction procedure.
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I am over 18 and have had AF symptoms confirmed by an ECG in the last year.
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I am not on any medication for irregular heartbeats as per my doctor's advice.
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I am scheduled for a procedure to correct my heart rhythm.

SOLUTION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Episodes of Tachycardia
Time to First Tachycardia Episode
Secondary outcome measures
Safety of Riluzole Neutropenia
Safety of Riluzole Pro-Arrhythmia

SOLUTION Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Riluzole 50mg BID
Group II: ControlPlacebo Group1 Intervention
Placebo Matching Double-Dummy Pills
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Riluzole 50 MG
2011
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Ohio State UniversityOTHER
823 Previous Clinical Trials
501,125 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
20 Patients Enrolled for Atrial Fibrillation
University of UtahLead Sponsor
1,092 Previous Clinical Trials
1,732,514 Total Patients Enrolled
12 Trials studying Atrial Fibrillation
1,997 Patients Enrolled for Atrial Fibrillation

Media Library

Riluzole (Neuronal-type Na+ channel blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05292209 — Phase 2
Atrial Fibrillation Research Study Groups: Control, Active
Atrial Fibrillation Clinical Trial 2023: Riluzole Highlights & Side Effects. Trial Name: NCT05292209 — Phase 2
Riluzole (Neuronal-type Na+ channel blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05292209 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this research endeavor?

"Affirmative. Clinicaltrials.gov data reveals that this clinical trial, which began recruiting participants on June 15th 2022 is still open for enrollment and has recently been updated on November 14th 2022. This medical study is seeking 78 volunteers from a single site."

Answered by AI

To what extent could Active be detrimental to people?

"Active's safety rating is 2, as the current available data demonstrates its security but not necessarily efficacy."

Answered by AI

Is recruitment still underway for this research trial?

"Clinicaltrials.gov reveals that this trial is actively seeking participants, with the initial post dating back to June 15th 2022 and most recent updates occurring on November 14th of the same year."

Answered by AI
~19 spots leftby Oct 2024