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

• Status: Terminated
• Trial end date: 2018-07-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan; Bonti, Inc.
• Treatments: Botulinum Toxins

Criteria

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.