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

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

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.

Study Overview

• Status: Terminated
• Conditions: Abdominoplasty
• Intervention / Treatment: Drug: Placebo; Biological: Botulinum Neurotoxin Serotype E

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research, LLC
    • Pasadena, California, United States, 91105
      • Huntington Ambulatory Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Drug: Placebo; Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
Experimental: Botulinum Neurotoxin Serotype E Dose 1; Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Biological: Botulinum Neurotoxin Serotype E; Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.; Other Names: EB-001; BoNT/E
Experimental: Botulinum Neurotoxin Serotype E Dose 2; Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Biological: Botulinum Neurotoxin Serotype E; Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.; Other Names: EB-001; BoNT/E
Experimental: Botulinum Neurotoxin Serotype E Dose 3; Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Biological: Botulinum Neurotoxin Serotype E; Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.; Other Names: EB-001; BoNT/E

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Joan-En Lin, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2018
• Primary Completion (Actual): July 10, 2018
• Study Completion (Actual): July 10, 2018

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: pain, neurotoxin
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: EB001-ABD201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No