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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Abdominoplasty

In brief

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.

Key facts

Study ID

NCT03429556

Run by

Allergan

People needed

23

Starts

2018-05-08

Expected to finish

2018-07-10

Last updated by the study team

2019-08-05

Who can join

Age: 23 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Huntington Ambulatory Surgery Center — Pasadena, California, United States
• Lotus Clinical Research, LLC — Pasadena, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.