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Sodium Channel Blocker

FlecIH-103 (flecainide acetate inhalation solution) for Atrial Fibrillation (RESTORE-1 Trial)

Phase 3
Waitlist Available
Research Sponsored by InCarda Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed AF is AF that has not been diagnosed previously, independent of its duration
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minutes
Awards & highlights

RESTORE-1 Trial Summary

This trial will evaluate if Flecainide Acetate, when inhaled, is more effective than a placebo in treating patients with recent onset atrial fibrillation. Approximately 400 people will be enrolled in the study and will be given either the drug or the placebo. The study will last for 24 weeks.

Eligible Conditions
  • Atrial Fibrillation

RESTORE-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
"Newly diagnosed AF" means that you have been diagnosed with atrial fibrillation for the first time, regardless of how long you have had it.

RESTORE-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of proportion of patients whose AF converts using continuous ECG monitoring
Secondary outcome measures
Assessing and comparing the AF related symptoms by using a questionnaire
Assessing and comparing the AF-related interventions prior to discharge between the active vs. placebo
Assessing and comparing the hospital admissions between the active vs. placebo
+2 more

RESTORE-1 Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: FlecIH-103 (flecainide acetate inhalation solution)Active Control1 Intervention
Up to two 3.5-minute inhalations separated by a 1-minute break, for a total duration of up to 8 minutes on Day 1. Dosing will continue until conversion of AF to SR is observed for ≥1 minute or the full dose (120 mg eTLD) is administered, whichever occurs first.
Group II: Vehicle-matched inhalation solution (placebo)Placebo Group1 Intervention
Up to two 3.5-minute inhalations separated by a 1-minute break, for a total duration of up to 8 minutes on Day 1.

Find a Location

Who is running the clinical trial?

InCarda Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
170 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
170 Patients Enrolled for Atrial Fibrillation
Luiz Belardinelli, MDStudy DirectorInCarda Therapeutics, Inc.
1 Previous Clinical Trials
170 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
170 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

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

Is FlecIH-103 (flecainide acetate inhalation solution) an FDA-verified medication?

"The safety of FlecIH-103 has been well documented in Phase 3 trials, so it received a score of 3 from our Power team."

Answered by AI

Are people with the specific ailment needed for this clinical trial able to participate at this time?

"The study is looking for participants and has all the necessary information posted on clinicaltrials.gov. The trial was first posted on 4/26/2022 and updated on the same day, meaning that the data is recent and reliable."

Answered by AI

Does this research exclude patients that are middle-aged or older?

"The age limit for patients participating in this study is 85 years old. So long as they are above 18, any patient is welcome."

Answered by AI
~19 spots leftby Mar 2025