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Neurotoxin

BOTOX for Ventral Hernia

Q: Are there any vacancies in the trial for participants?

Sadly, this clinical trial is no longer seeking applicants. It was initially posted on May 22nd 2023 and the last update occured on November 4th 2022. Nevertheless, there exist 161 other studies that are actively recruiting volunteers currently.

Q: What safety measures are taken to protect patients in Cohort 2, receiving BOTOX Dose A?

There is some evidence of safety with Cohort 2, BOTOX Dose A, so it was awarded a score of 2. As this trial is only at Phase 2, there is no data supporting efficacy yet.

Q: What is the age threshold for participants in this study?

This trial is open to applicants who are at least 18 years of age and no more than 80.

Q: Is my eligibility sufficient to partake in this trial?

To qualify for this study, individuals must have a <a href="https://www.withpower.com/clinical-trials/hernia">hernia</a> and be between 18-80 years old. This clinical trial is searching for approximately 200 participants.

Q: Are there numerous sites executing this medical study in Canada?

This clinical trial can be accessed at the University of <a href="https://www.withpower.com/clinical-trials/florida">Florida</a> - Archer /ID# 247712 in Gainesville, as well as Atrium Health Carolinas Medical Center /ID# 247711 in Charlotte and Cleveland Clinic Main Campus /ID# 247411 in Cleveland. Six additional sites are also participating in this research.

Phase 2

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months

Awards & highlights

Study Summary

This trial is testing an investigational drug (BOTOX) to treat ventral hernias. 200 participants will receive 1 of 3 BOTOX doses or placebo and be assessed over 3 months.

Who is the study for?

This trial is for adults with a specific type of abdominal hernia, who are in good health and have a BMI <= 40 kg/m2. They should not have had certain recent surgeries or conditions that affect breathing, no severe allergies to BOTOX, and no neuromuscular diseases like muscular dystrophy.Check my eligibility

What is being tested?

The study tests different doses of onabotulinumtoxinA (BOTOX) versus placebo in patients undergoing ventral hernia repair surgery. It aims to see if BOTOX helps close the hernia without additional surgical techniques. Participants will be followed for about three months post-surgery.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, muscle weakness near where the drug was injected, fatigue, headache, neck pain, eye problems such as blurred vision or drooping eyelids, allergic reactions like itching or rash.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months 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 achievement of primary fascial closure (PFC) without the use of component separation techniques (CST) in open ventral hernia surgical repair

Secondary outcome measures

Screening procedure

Change in Width to the Hernia Defect

+4 more

Trial Design

11Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 3, PlaceboExperimental Treatment1 Intervention

Participants will receive placebo for BOTOX.

Group II: Cohort 3, BOTOX Dose CExperimental Treatment1 Intervention

Participants will receive BOTOX Dose C.

Group III: Cohort 3, BOTOX Dose BExperimental Treatment1 Intervention

Participants will receive BOTOX Dose B.

Group IV: Cohort 3, BOTOX Dose AExperimental Treatment1 Intervention

Participants will receive BOTOX Dose A

Group V: Cohort 2, BOTOX Dose CExperimental Treatment1 Intervention

Participants will receive BOTOX Dose C

Group VI: Cohort 2, BOTOX Dose BExperimental Treatment1 Intervention

Participants will receive BOTOX Dose B

Group VII: Cohort 2, BOTOX Dose AExperimental Treatment1 Intervention

Participants will receive BOTOX Dose A

Group VIII: Cohort 1, BOTOX Dose BExperimental Treatment1 Intervention

Participants will receive BOTOX Dose B.

Group IX: Cohort 1, BOTOX Dose AExperimental Treatment1 Intervention

Participants will receive BOTOX Dose A

Group X: Cohort 2, PlaceboPlacebo Group1 Intervention

Participants will receive placebo for BOTOX

Group XI: Cohort 1, PlaceboPlacebo Group1 Intervention

Participants will receive placebo for BOTOX.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,184 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,898 Total Patients Enrolled

Media Library

OnabotulinumtoxinA (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05606757 — Phase 2

Ventral Hernia Research Study Groups: Cohort 3, BOTOX Dose B, Cohort 2, Placebo, Cohort 1, Placebo, Cohort 3, BOTOX Dose C, Cohort 3, BOTOX Dose A, Cohort 2, BOTOX Dose C, Cohort 1, BOTOX Dose A, Cohort 1, BOTOX Dose B, Cohort 3, Placebo, Cohort 2, BOTOX Dose A, Cohort 2, BOTOX Dose B

Ventral Hernia Clinical Trial 2023: OnabotulinumtoxinA Highlights & Side Effects. Trial Name: NCT05606757 — Phase 2

OnabotulinumtoxinA (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05606757 — Phase 2

Frequently Asked Questions

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

Are there any vacancies in the trial for participants?

"Sadly, this clinical trial is no longer seeking applicants. It was initially posted on May 22nd 2023 and the last update occured on November 4th 2022. Nevertheless, there exist 161 other studies that are actively recruiting volunteers currently."

Answered by AI

What safety measures are taken to protect patients in Cohort 2, receiving BOTOX Dose A?

"There is some evidence of safety with Cohort 2, BOTOX Dose A, so it was awarded a score of 2. As this trial is only at Phase 2, there is no data supporting efficacy yet."

Answered by AI

What is the age threshold for participants in this study?

"This trial is open to applicants who are at least 18 years of age and no more than 80."

Answered by AI

Is my eligibility sufficient to partake in this trial?

"To qualify for this study, individuals must have a hernia and be between 18-80 years old. This clinical trial is searching for approximately 200 participants."

Answered by AI

Are there numerous sites executing this medical study in Canada?

"This clinical trial can be accessed at the University of Florida - Archer /ID# 247712 in Gainesville, as well as Atrium Health Carolinas Medical Center /ID# 247711 in Charlotte and Cleveland Clinic Main Campus /ID# 247411 in Cleveland. Six additional sites are also participating in this research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Adverse Events and Effectiveness of OnabotulinumtoxinA in Participants Undergoing Open Abdominal Ventral Hernia Repair for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique

2023. "A Study to Evaluate Adverse Events and Effectiveness of OnabotulinumtoxinA in Participants Undergoing Open Abdominal Ventral Hernia Repair for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05606757.

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