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

Allergan

Status and phase: Terminated; Phase 2

Conditions: Abdominoplasty

Treatments: Biological: Botulinum Neurotoxin Serotype E; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03429556

EB001-ABD201

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 23 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men or women 23 to 55 years of age, inclusive
2. 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
3. American Society of Anesthesiologist (ASA) Physical Class 1-2.

Exclusion criteria

1. History of prior major abdominal surgery as judged by the investigator
2. Pre-existing lung disease that could impact participant safety in the opinion of the investigator
3. Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis)
4. At high risk of deep vein thrombosis as judged by the investigators determined by a Caprini score of 3 or higher
5. 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
6. Pulse oximetry below 95%
7. Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32
8. Reported use of any botulinum toxin within 3 months prior to the date of surgery
9. Use of long acting opioids within 3 days or any opioid medication within 24 hours prior to surgery
10. Aminoglycoside intake within 48 hours prior to or during surgery
11. Participants on anti-depressant or anti-psychotic medications
12. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.

Treatment:

Drug: Placebo

Botulinum Neurotoxin Serotype E Dose 1

Experimental group

Description:

Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.

Treatment:

Biological: Botulinum Neurotoxin Serotype E

Botulinum Neurotoxin Serotype E Dose 2

Experimental group

Description:

Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.

Treatment:

Biological: Botulinum Neurotoxin Serotype E

Botulinum Neurotoxin Serotype E Dose 3

Experimental group

Description:

Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.

Treatment:

Biological: Botulinum Neurotoxin Serotype E