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Dose Escalation Study to Assess Safety, Tolerability, and Efficacy of Budiodarone Treatment With Non-permanent Atrial Fibrillation

ConditionsAtrial Fibrillation (AF)Paroxysmal AF
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXyra, LLC

About this trial

This multicenter, open-label study aims to assess the safety, tolerability and efficacy of budiodarone in treating participants with non-permanent AF, in particular paroxysmal atrial fibrillation (PAF). The trial will serve as a 6-month safety and a proof-of-concept study for a dose escalation strategy using AF monitoring, enrolling approximately 100 participants who will undergo 24 weeks of treatment. The study aims to evaluate the feasibility of dose escalation through AF monitoring of long episodes atrial fibrillation last 5 hours or longer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Proven paroxysmal atrial fibrillation or undergoing first-time elective electrical (direct current) cardioversion for persistent atrial fibrillation, or second-time elective electrical (direct current) cardioversion.

Baseline AF Criteria: To qualify for treatment, each participant must have during the 28-day baseline period an AFB greater than 5% and one of the following qualifying events: 1) 2 continuous AF episodes (LEAF) of 5 hours or longer; or 2) 2 rolling 24-hour periods in which cumulative AF duration is 5 hours or longer; or 3) 1 continuous AF episode (LEAF) of 5 hours or longer plus 1 rolling 24-hour period in which cumulative AF duration is 5 hours or longer

Must have failed at least one prior therapy for AF

Must have an AFSS greater than 3.

Disqualifiers

NYHA Class 3 or 4 heart failure.

MI, ischemic stroke, or any clinically relevant venous thromboembolism within 3 months of screening.

Unstable angina, percutaneous transluminal coronary angioplasty (PTCA), or CABG within 3 months of screening.

Prolonged QTcF Interval with a normal QRS duration (>500 ms with QRS ≤120 ms).

Trial design

Design model

Single group

Treatments tested in this trial

  • Budiodarone 200 mg BID

    Drug

    Budiodarone is formulated as 200 mg capsules, to be administered as 1 capsule (200mg) twice a day (BID).

  • Budiodarone 400 mg BID

    Drug

    Budiodarone is formulated as 200 mg capsules, to be administered as 2 capsules (400 mg) BID.

  • Budiodarone 600 mg BID

    Drug

    Budiodarone is formulated as 200 mg capsules, to be administered as 3 capsules (600 mg) BID.

  • Budiodarone 800 mg BID

    Drug

    Budiodarone is formulated as 200 mg capsules, to be administered as 4 capsules (800 mg) BID.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: BudiodaroneExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Proportion of participants that have no long episodes of atrial fibrillation (LEAF) in the final month of treatment

Proportion of participants that have no LEAF (uninterrupted episode of AF of 5 hours or longer in duration or cumulative duration of AF in any rolling 24-hour period that is 5 hours or longer) in the final month of treatment.

Time frame
24 weeks

Secondary outcomes

1

Percent Change in Atrial Fibrillation Burden (AFB)

Percent change in AFB during final month of treatment compared to baseline.

Time frame
24 weeks
2

Change in percent of Atrial Fibrillation Severity Scale (AFSS) during final month of treatment.

The University of Toronto Atrial Fibrillation Severity Scale (AFSS) is a patient-reported outcome instrument developed to quantify atrial fibrillation (AF). In this study, Part C of the scale will be used. In Part C, participants are asked to asses how AF symptoms affect daily activities, physical functioning, and overall quality of life. The minimum score is 0 and the maximum score is 35. Higher scores reflect greater impairment from AF-related symptoms. AFSS score during final month of treatment will be compared to baseline for multiple doses of budiodarone.

Time frame
24 weeks
3

Patient Global Impression of Change (PGI-C) during the final month of treatment

The Patient Global Impression of Change (PGI-C) is a two-question instrument that employs a Likert scale to assess participants' perceived changes in AF symptom control and overall satisfaction. Response options for symptom control include: Made them worse, No change, Slight improvement, Moderate improvement, A lot of improvement, and Complete relief. For overall satisfaction, participants choose from: Not at all, A little bit, Somewhat, A lot, and Completely.

Time frame
24 weeks

Other outcomes

1

Safety Assessment

Incidence of treatment-emergent adverse events (TEAE) and treatment-emergent serious adverse events (TESAE)

Time frame
24 weeks
2

Safety Assessment

Incidence of adverse events of special interest (AESI)

Time frame
24 weeks
3

Safety Assessments

Incidence of death

Time frame
24 weeks
4

Safety Assessment

Incidence of resuscitated sudden cardiac death

Time frame
24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xyra, LLC

Lead sponsor

Amarex Clinical Research

Collaborator

Source ClinicalTrials.gov
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