Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty

Study Overview
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Brief Summary
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To determine the safety and efficacy of single intra-operative treatment of Botulinum Neurotoxin Serotype E (EB-001) intramuscular (IM) injections into the Rectus Abdominus (RA) in participants undergoing abdominoplasty.

Official Title
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A Phase 2 Study to Evaluate Safety and Efficacy of EB-001 Intramuscular (IM) Injections in Reducing Musculoskeletal Pain in Subjects Undergoing Elective Abdominoplasty Surgery

Conditions
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Abdominoplasty

Intervention / Treatment
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* Biological: Botulinum Neurotoxin Serotype E
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 23 to 55 years of age, inclusive Scheduled to undergo elective abdominoplasty surgery with full length plication from xyphoid to pubis, and removal of skin/fat flap under general anesthesia (endotracheal or otherwise) without liposuction American Society of Anesthesiologist (ASA) Physical Class 1-2. Exclusion Criteria: History of prior major abdominal surgery as judged by the investigator Pre-existing lung disease that could impact participant safety in the opinion of the investigator Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis) At high risk of deep vein thrombosis as judged by the investigators determined by a Caprini score of 3 or higher Slow vital capacity that is below 80% of normal value for respective race, age, height, and gender or below 2.5 Liters (L) of absolute volume Pulse oximetry below 95% Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32 Reported use of any botulinum toxin within 3 months prior to the date of surgery Use of long acting opioids within 3 days or any opioid medication within 24 hours prior to surgery Aminoglycoside intake within 48 hours prior to or during surgery Participants on anti-depressant or anti-psychotic medications Reported pain score of 2 or more at screening on the 11-point scale numerical pain rating scale-administered after an activity (NPRS-A) following an activity after and walking approximately 10 feet.

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery. | Drug: Placebo<br>* Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.<br>|
| Experimental: Botulinum Neurotoxin Serotype E Dose 1<br>Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery. | Biological: Botulinum Neurotoxin Serotype E<br>* Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.<br>* Other names: BoNT/E;|
| Experimental: Botulinum Neurotoxin Serotype E Dose 2<br>Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery. | Biological: Botulinum Neurotoxin Serotype E<br>* Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.<br>* Other names: BoNT/E;|
| Experimental: Botulinum Neurotoxin Serotype E Dose 3<br>Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery. | Biological: Botulinum Neurotoxin Serotype E<br>* Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.<br>* Other names: BoNT/E;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96) | The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule. | Every 2 hours from 12 to 96 hours postsurgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery | The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule. | Every 2 hours from 0 to 96 hours postsurgery | 
| AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72) | The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule. | Every 2 hours from 0 to 72 hours postsurgery | 
| AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48) | The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule. | Every 2 hours from 0 to 48 hours postsurgery | 
| AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24) | The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule. | Every 2 hours from 0 to 24 hours postsurgery | 
| AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24) | The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule. | Every 2 hours from 12 to 24 hours postsurgery | 
| Participants Overall Assessment of Pain Using the NPRS After Discharge | The participant assessed their pain after discharge using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. | Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26 | 
| Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) | The participant assessed their pain using the 11-point NPRS-A, after sitting up in the bed unassisted at an angle of approximately ≥ 45 degrees, swinging legs out, putting feet down, standing up, and walking approximately 10 feet, where: 0=no pain to 10=worst pain imaginable. | 8, 16, 24, 30, 36, 42, 48, 54, 60, 66, 72.78.84, and 96 hours after surgery; Days 8, 15 and 29 after discharge | 
| Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories | The participant assessed their overall pain control in the past 24 hours using the PGA 4-point scale where: 0=poor, 1=fair, 2=good and 3=excellent. | Days 5, 8, 15 and 29 | 
| Number of Doses of Rescue Medications Used |  | Up to 96 hours postsurgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, neurotoxin