Ventral HerniaPhase 2NCT05606757

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

A Phase 2 study testing BOTOX Dose A, BOTOX Dose B and BOTOX Dose C in people with Ventral Hernia and Abdominal Hernia, run by AbbVie at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Ventral hernias form when there is a loss of integrity of the abdominal wall muscles. Abdominal hernias can expand and can cause severe pain as the abdominal wall weakens. The purpose of this study is to evaluate the safety and efficacy of a range of onabotulinumtoxinA (BOTOX) doses to achieve primary fascial closure… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Ventral Hernia, Abdominal Hernia
What is being tested?: BOTOX Dose A, BOTOX Dose B and BOTOX Dose C
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 2 sitesUnited States
Study dates: 7 May 2024to 26 Sep 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant is in good health as determined by medical history, vital signs, and investigator's judgment, including no known active pandemic infection.
Body Mass Index (BMI) at screening is <= 40 kg/m2.
Participant meets the following disease activity criteria:
Intact abdominal wall muscles (defined as no prior dissection to the lateral abdominal wall complex) based on screening CT scan.
Midline ventral hernia requiring surgical repair, at least 6 cm, and not more than 18 cm in transverse defect width at the widest part of the of the hernia defect, as assessed on CT scan by the investigator.
Any portion of the ventral hernia does not extend > 3 cm into the M1 subxiphoid zone or into the M5 zone using the 2009 classification by the European Hernia Society.
No history of prior onlay hernia mesh wider than rectus.
No hernia with loss of domain >20% as determined by the investigator, using Sabbagh method.

Who cannot join

Presence of a medical condition that may put the participant at increased risk with exposure to onabotulinumtoxinA, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function.
Presence or history of any of the following within 3 months prior to the randomization visit that may indicate a vulnerable respiratory state per the investigator's clinical judgment, for example, aspiration pneumonia, lower respiratory tract infections, uncontrolled asthma, severe chronic obstructive pulmonary disease, or otherwise compromised respiratory function.
History of ongoing or anticipated need to perform progressive preoperative pneumoperitoneum or other tissue expansion technique for repair of ventral hernia.
Planned ostomy reversal, panniculectomy bariatric procedure, or vascular procedure requiring anticoagulants during the study.
History of abdominal or hernia repair surgery requiring hospitalization within 6 months prior to screening.
History of a contraindication to BOTOX and/or hypersensitivity reactions to BOTOX.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Atrium Health Carolinas Medical Center /ID# 247711
Charlotte, North Carolina, 28203
NYU Langone Hospital - Long Island /ID# 251280
Mineola, New York, 11501

Other trials in United States

About this study

Official title: A Phase 2b Double-Blind, Placebo-Controlled, Adaptive, Dose-Escalation Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique, in Subjects Undergoing Open Abdominal Ventral Hernia Repair

BOTOX is an investigational drug being developed for the treatment of ventral hernias. In this dose escalation study, participants will be placed in 1 of 3 cohorts. Cohort 1 will be randomized to receive placebo or 1 of 2 BOTOX doses, after which time Cohort 2 will be randomized to receive placebo or 1 of 3 BOTOX doses. Participants in Cohort 3 will be randomized to receive placebo or 1 of 3 BOTOX doses. Adult participants undergoing open abdominal ventral hernia repair will be enrolled. Around 200 participants will be enrolled in the study at approximately 20 sites in the United States.

Participants will receive a single intramuscular injection of BOTOX Dose A, BOTOX Dose B, BOTOX Dose C, or placebo.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will be followed for approximately 3 months after surgery and will receive a follow-up phone call 30 days (+/-) their last study visit. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions: Ventral Hernia, Abdominal Hernia
Being tested: BOTOX Dose A, Placebo for BOTOX, BOTOX Dose B, BOTOX Dose C
Keywords: OnabotulinumtoxinA, BOTOX, Abdomen, Primary fascial closure
Medical subject headings: Hernia, Ventral, Hernia, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BOTOX Dose ADrug
Also called OnabotulinumtoxinA
Injection; intramuscular
Placebo for BOTOXDrug
Placebo
BOTOX Dose BDrug
Also called OnabotulinumtoxinA
Injection; intramuscular
BOTOX Dose CDrug
Also called OnabotulinumtoxinA
Injection; intramuscular

Study groups in NCT05606757
Study group	Role	What they receive
Cohort 1, BOTOX Dose A	Experimental	Participants will receive BOTOX Dose A Receives: Drug: BOTOX Dose A
Cohort 1, BOTOX Dose B	Experimental	Participants will receive BOTOX Dose B. Receives: Drug: BOTOX Dose B
Cohort 1, Placebo	Placebo comparator	Participants will receive placebo for BOTOX. Receives: Drug: Placebo for BOTOX
Cohort 2, BOTOX Dose A	Experimental	Participants will receive BOTOX Dose A Receives: Drug: BOTOX Dose A
Cohort 2, BOTOX Dose B	Experimental	Participants will receive BOTOX Dose B Receives: Drug: BOTOX Dose B
Cohort 2, BOTOX Dose C	Experimental	Participants will receive BOTOX Dose C Receives: Drug: BOTOX Dose C
Cohort 2, Placebo	Placebo comparator	Participants will receive placebo for BOTOX Receives: Drug: Placebo for BOTOX
Cohort 3, BOTOX Dose A	Experimental	Participants will receive BOTOX Dose A Receives: Drug: BOTOX Dose A
Cohort 3, BOTOX Dose B	Experimental	Participants will receive BOTOX Dose B. Receives: Drug: BOTOX Dose B
Cohort 3, BOTOX Dose C	Experimental	Participants will receive BOTOX Dose C. Receives: Drug: BOTOX Dose C
Cohort 3, Placebo	Experimental	Participants will receive placebo for BOTOX. Receives: Drug: Placebo for BOTOX

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of participants with achievement of primary fascial closure (PFC) without the use of component separation techniques (CST) in open ventral hernia surgical repair
PFC will be defined as the ability to achieve fascia to fascia midline approximation. CST will be defined as the release of the external oblique muscle or the transection of transversus abdominis muscle (known as posterior component separation with transversus abdominis release (TAR).
Measured: Up to 4 Months

Secondary outcomes (7)

Percentage of participants with achievement of PFC
PFC will be defined as the ability to achieve fascia to fascia midline approximation.
Measured: Up to 4 Months
Percentage of participants with usage of CST for the purpose of PFC
CST will be defined as the release of the external oblique muscle or the transection of transversus abdominis muscle (known as posterior component separation with transversus abdominis release (TAR).
Measured: Up to 4 Months
Number of lateral abdominal wall muscles released among participants who required CST use to achieve PFC as reported by the operating surgeon
Lateral abdominal wall muscles are released by TAR and external oblique release (unilateral or bilateral)
Measured: Up to 4 Months
Change in length of lateral abdominal wall complex
Change in length of lateral abdominal wall complex as measured by abdominal CT scan in supine position prior to surgical repair will be assessed.
Measured: Up to 4 Months
Change in Width to the Hernia Defect
Change from screening in width to the hernia defect as measured by abdominal CT scan in supine position prior to surgical repair will be assessed.
Measured: Up to 4 Months
Change from screening in length of lateral abdominal wall complex
Change from screening in length of lateral abdominal wall complex as measured by abdominal CT scan performing Valsalva maneuver prior to surgical repair will be assessed.
Measured: Up to 4 Months
Change from screening in width to the hernia defect
Change from screening in width to the hernia defect as measured by abdominal CT scan performing Valsalva maneuver prior to surgical repair
Measured: Up to 4 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 May 202426 Sep 2025

First posted7 Nov 2022
Study start7 May 2024 (estimated)
Primary completion22 Apr 2025 (estimated)
Study completion26 Sep 2025 (estimated)

Why it stopped: Strategic considerations

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ventral HerniaStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05606757
Sponsor's protocol ID: M21-779
Status last verified: May 2024
First submitted: 1 Nov 2022
Last updated: 16 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia

All Ventral Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b Double-Blind, Placebo-Controlled, Adaptive, Dose-Escalation Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique, in Subjects Undergoing Open Abdominal Ventral Hernia Repair
ClinicalTrials.gov ID: NCT05606757
Acronym / sponsor ID: M21-779
Conditions: Ventral Hernia, Abdominal Hernia
Keywords: OnabotulinumtoxinA, BOTOX, Abdomen, Primary fascial closure
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Strategic considerations
Enrolment: 0 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 7 May 2024 (estimated)
Primary completion: 22 Apr 2025 (estimated)
Study completion: 26 Sep 2025 (estimated)
First posted: 7 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants will receive a single intramuscular injection of BOTOX Dose A, BOTOX Dose B, BOTOX Dose C, or placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 11

Arm	Type	Receives
Cohort 1, BOTOX Dose A	Experimental	Drug: BOTOX Dose AParticipants will receive BOTOX Dose A
Cohort 1, BOTOX Dose B	Experimental	Drug: BOTOX Dose BParticipants will receive BOTOX Dose B.
Cohort 1, Placebo	Placebo comparator	Drug: Placebo for BOTOXParticipants will receive placebo for BOTOX.
Cohort 2, BOTOX Dose A	Experimental	Drug: BOTOX Dose AParticipants will receive BOTOX Dose A
Cohort 2, BOTOX Dose B	Experimental	Drug: BOTOX Dose BParticipants will receive BOTOX Dose B
Cohort 2, BOTOX Dose C	Experimental	Drug: BOTOX Dose CParticipants will receive BOTOX Dose C
Cohort 2, Placebo	Placebo comparator	Drug: Placebo for BOTOXParticipants will receive placebo for BOTOX
Cohort 3, BOTOX Dose A	Experimental	Drug: BOTOX Dose AParticipants will receive BOTOX Dose A
Cohort 3, BOTOX Dose B	Experimental	Drug: BOTOX Dose BParticipants will receive BOTOX Dose B.
Cohort 3, BOTOX Dose C	Experimental	Drug: BOTOX Dose CParticipants will receive BOTOX Dose C.
Cohort 3, Placebo	Experimental	Drug: Placebo for BOTOXParticipants will receive placebo for BOTOX.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Participant is in good health as determined by medical history, vital signs, and investigator's judgment, including no known active pandemic infection.
Body Mass Index (BMI) at screening is <= 40 kg/m2.
Participant meets the following disease activity criteria:

Key exclusion criteria (6 listed)

Presence of a medical condition that may put the participant at increased risk with exposure to onabotulinumtoxinA, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function.
Presence or history of any of the following within 3 months prior to the randomization visit that may indicate a vulnerable respiratory state per the investigator's clinical judgment, for example, aspiration pneumonia, lower respiratory tract infections, uncontrolled asthma, severe chronic obstructive pulmonary disease, or otherwise compromised respiratory function.
History of ongoing or anticipated need to perform progressive preoperative pneumoperitoneum or other tissue expansion technique for repair of ventral hernia.
Planned ostomy reversal, panniculectomy bariatric procedure, or vascular procedure requiring anticoagulants during the study.
History of abdominal or hernia repair surgery requiring hospitalization within 6 months prior to screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BOTOX Dose AAlso: OnabotulinumtoxinAInjection; intramuscular	Drug	Cohort 1, BOTOX Dose A, Cohort 2, BOTOX Dose A, Cohort 3, BOTOX Dose A
Placebo for BOTOXPlacebo	Drug	Cohort 1, Placebo, Cohort 2, Placebo, Cohort 3, Placebo
BOTOX Dose BAlso: OnabotulinumtoxinAInjection; intramuscular	Drug	Cohort 1, BOTOX Dose B, Cohort 2, BOTOX Dose B, Cohort 3, BOTOX Dose B
BOTOX Dose CAlso: OnabotulinumtoxinAInjection; intramuscular	Drug	Cohort 2, BOTOX Dose C, Cohort 3, BOTOX Dose C

Primary outcome

Percentage of participants with achievement of primary fascial closure (PFC) without the use of component separation techniques (CST) in open ventral hernia surgical repair
Time frame: Up to 4 Months
PFC will be defined as the ability to achieve fascia to fascia midline approximation. CST will be defined as the release of the external oblique muscle or the transection of transversus abdominis muscle (known as posterior component separation with transversus abdominis release (TAR).

7 secondary outcomes

Percentage of participants with achievement of PFC
Time frame: Up to 4 Months
Percentage of participants with usage of CST for the purpose of PFC
Time frame: Up to 4 Months
Number of lateral abdominal wall muscles released among participants who required CST use to achieve PFC as reported by the operating surgeon
Time frame: Up to 4 Months
Change in length of lateral abdominal wall complex
Time frame: Up to 4 Months
Change in Width to the Hernia Defect
Time frame: Up to 4 Months
Change from screening in length of lateral abdominal wall complex
Time frame: Up to 4 Months
Change from screening in width to the hernia defect
Time frame: Up to 4 Months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Related trials for Ventral Hernia

Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ABBVIE INC. study director

AbbVie

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BOTOX Dose A, BOTOX Dose B and BOTOX Dose C in people with Ventral Hernia and Abdominal Hernia, run by AbbVie at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with achievement of primary fascial closure (PFC) without the use of component separation techniques (CST) in open ventral hernia surgical repair (time frame: Up to 4 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05606757.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.