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

NCT05606757 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: M21-779
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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 (PFC) without use of component separation technique (CST) in ventral hernia surgical 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

Keywords

OnabotulinumtoxinA; BOTOX; Abdomen; Primary fascial closure

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 4 Months

Secondary Outcomes (7)

• Percentage of participants with achievement of PFC

  Up to 4 Months

• Percentage of participants with usage of CST for the purpose of PFC

  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

  Up to 4 Months

• Change in length of lateral abdominal wall complex

  Up to 4 Months

• Change in Width to the Hernia Defect

  Up to 4 Months

Study Arms (11)

Cohort 1, BOTOX Dose A

EXPERIMENTAL

Participants will receive BOTOX Dose A

Drug: BOTOX Dose A

Cohort 1, BOTOX Dose B

EXPERIMENTAL

Participants will receive BOTOX Dose B.

Drug: BOTOX Dose B

Cohort 1, Placebo

PLACEBO COMPARATOR

Participants will receive placebo for BOTOX.

Drug: Placebo for BOTOX

Cohort 2, BOTOX Dose A

EXPERIMENTAL

Participants will receive BOTOX Dose A

Drug: BOTOX Dose A

Cohort 2, BOTOX Dose B

EXPERIMENTAL

Participants will receive BOTOX Dose B

Drug: BOTOX Dose B

Cohort 2, BOTOX Dose C

EXPERIMENTAL

Participants will receive BOTOX Dose C

Drug: BOTOX Dose C

Cohort 2, Placebo

PLACEBO COMPARATOR

Participants will receive placebo for BOTOX

Drug: Placebo for BOTOX

Cohort 3, BOTOX Dose A

EXPERIMENTAL

Participants will receive BOTOX Dose A

Drug: BOTOX Dose A

Cohort 3, BOTOX Dose B

EXPERIMENTAL

Participants will receive BOTOX Dose B.

Drug: BOTOX Dose B

Cohort 3, BOTOX Dose C

EXPERIMENTAL

Participants will receive BOTOX Dose C.

Drug: BOTOX Dose C

Cohort 3, Placebo

EXPERIMENTAL

Participants will receive placebo for BOTOX.

Drug: Placebo for BOTOX

Interventions

BOTOX Dose A DRUG

Injection; intramuscular

Also known as: OnabotulinumtoxinA

Cohort 1, BOTOX Dose A; Cohort 2, BOTOX Dose A; Cohort 3, BOTOX Dose A

Placebo for BOTOX DRUG

Placebo

Cohort 1, Placebo; Cohort 2, Placebo; Cohort 3, Placebo

BOTOX Dose B DRUG

Injection; intramuscular

Also known as: OnabotulinumtoxinA

Cohort 1, BOTOX Dose B; Cohort 2, BOTOX Dose B; Cohort 3, BOTOX Dose B

BOTOX Dose C DRUG

Injection; intramuscular

Also known as: OnabotulinumtoxinA

Cohort 2, BOTOX Dose C; Cohort 3, BOTOX Dose C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (2)

NYU Langone Hospital - Long Island /ID# 251280

Mineola, New York, 11501, United States

Location

Atrium Health Carolinas Medical Center /ID# 247711

Charlotte, North Carolina, 28203, United States

Location

Related Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

MeSH Terms

Conditions

Hernia, Ventral; Hernia, Abdominal

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 7, 2022
• Study Start: May 7, 2024
• Primary Completion: April 22, 2025
• Study Completion: September 26, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (2)