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

Phase 2

Terminated

• Conditions: Abdominoplasty
• Interventions: Drug: Placebo; Biological: Botulinum Neurotoxin Serotype E

• Registration Number: NCT03429556
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-12
• Study Start: 2018-05-08
• Primary Completion: 2018-07-10
• Study Completion: 2018-07-10
• Results First Submitted: 2019-07-02
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-01
• Last Update Submitted: 2019-08-01
• Results First Posted: 2019-08-05
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
Botulinum Neurotoxin Serotype E Dose 3	Botulinum Neurotoxin Serotype E	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.

Primary Outcome Measures

Name	Time	Method
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)	Every 2 hours from 12 to 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.

Secondary Outcome Measures

Name	Time	Method
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72)	Every 2 hours from 0 to 72 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.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24)	Every 2 hours from 12 to 24 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.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48)	Every 2 hours from 0 to 48 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.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery	Every 2 hours from 0 to 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.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24)	Every 2 hours from 0 to 24 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.
Participants Overall Assessment of Pain Using the NPRS After Discharge	Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26	The participant assessed their pain after discharge using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A)	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	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.
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories	Days 5, 8, 15 and 29	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.
Number of Doses of Rescue Medications Used	Up to 96 hours postsurgery

Trial Locations

Locations (2)

Huntington Ambulatory Surgery Center; 🇺🇸 Pasadena, California, United States

Lotus Clinical Research, LLC; 🇺🇸 Pasadena, California, United States