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Neurotoxin

AGN-151607 for Atrial Fibrillation

Phase 2
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.
Written informed consent from the participant has been obtained prior to any study-related procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial will test whether botulinum toxin type A can prevent atrial fibrillation after open-chest cardiac surgery.

Eligible Conditions
  • Post-operative Atrial Fibrillation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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
Percentage of participants with at least 1 continuous atrial fibrillation (AF) episode ≥ 30 seconds during the first 30 days post-surgery.
Secondary outcome measures
Percentage of participants with at least 1 continuous AF episode ≥ 1 hour during the first 30 days post-surgery
Percentage of participants with at least 1 continuous AF episode ≥ 12 hours during the first 30 days post-surgery
Percentage of participants with at least 1 continuous AF episode ≥ 2 minutes during the first 30 days post-surgery
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: AGN-151607 (250 U)Experimental Treatment1 Intervention
Injections of 50 U will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
Group II: AGN-151607 (125 U)Experimental Treatment1 Intervention
Injections of 25 U will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
Group III: PlaceboPlacebo Group1 Intervention
Injections of placebo will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AGN-151607
2019
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
275,463 Total Patients Enrolled
AbbVieLead Sponsor
945 Previous Clinical Trials
496,073 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
140,826 Total Patients Enrolled

Frequently Asked Questions

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

Are patients who are over 55 years old able to participate in this clinical trial?

"This geriatric clinical trial is looking for patients who are within the age bracket of 55 to 90 years old."

Answered by AI

Is this trial available in many locations within the city?

"Currently, this clinical trial is operational in 26 locations. They are situated in Falls Church, Saint Louis, and Montréal as well as 24 other sites. If you enroll in the trial, it would be advantageous to pick a location near you to limit travel needs."

Answered by AI

Are there any available spots for new participants in this trial?

"Unfortunately, this particular clinical trial is not recruiting at the moment. According to information on clinicaltrials.gov, it was initially posted on March 1st 2019 and edited for the last time on April 8th 2022. Even though this study isn't looking for volunteers right now, there are 501 other trials that are currently enrolling patients."

Answered by AI

What is the AGN-151607's regulatory status?

"AGN-151607's safety is based on Phase 2 trial data, which means that while there is some evidence indicating it is safe, there is no indication of its efficacy."

Answered by AI

Can I qualify to participate in this research?

"This trial is recruiting 330 patients with atrial fibrillation aged 55 and 90. Most importantly, patients should meet the following criteria: Written informed consent from the participant has been obtained prior to any study-related procedures, Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form., Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg. Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent (European Union sites)., Participants who are scheduled to undergo open-chest cardiac surgery"

Answered by AI
~55 spots leftby Mar 2025