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

• Sponsor: Allergan (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03429556
• Collaborator: (none)
• Enrollment: 23
• Locations: 2
• Arms: 4
• Actual Duration (Months): 2.1
• Patients Per Site: 11.5
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominoplasty	Biological: Botulinum Neurotoxin Serotype E; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: May 8, 2018
• Actual Primary Completion Date: Jul 10, 2018
• Actual Study Completion Date: Jul 10, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. Number of Doses of Rescue Medications Used [Up to 96 hours postsurgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huntington Ambulatory Surgery Center	Pasadena	California	United States	91105
2	Lotus Clinical Research, LLC	Pasadena	California	United States	91105

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Joan-En Lin, Allergan

Study Documents (Full-Text)

• Study Protocol - Sep 28, 2018
• Statistical Analysis Plan - May 9, 2018

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT03429556
• Other Study ID Numbers: EB001-ABD201
• First Posted: Feb 12, 2018
• Last Update Posted: Aug 5, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Allergan: pain, neurotoxin
• Additional relevant MeSH terms: Musculoskeletal Pain; Botulinum Toxins

Study Results

Participant Flow

Arm/Group Title	Placebo	Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E Dose 3
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into rectus abdominus (RA) muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Period Title: Overall Study
STARTED	12	4	4	3
COMPLETED	12	3	4	3
NOT COMPLETED	0	1	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E Dose 3	Total
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Total of all reporting groups
Overall Participants	12	4	4	3	23
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.5 (5.2)	33.0 (6.38)	36.3 (7.72)	41.0 (14.0)	36.7 (3.29)
Sex: Female, Male (Count of Participants)
Female	11 91.7%	4 100%	4 100%	3 100%	22 95.7%
Male	1 8.3%	0 0%	0 0%	0 0%	1 4.3%
Race/Ethnicity, Customized (Count of Participants)
Asian	0 0%	0 0%	1 25%	0 0%	1 4.3%
Black or African American	5 41.7%	3 75%	1 25%	2 66.7%	11 47.8%
White or Caucasian	6 50%	1 25%	2 50%	1 33.3%	10 43.5%
Other/Mixed	1 8.3%	0 0%	0 0%	0 0%	1 4.3%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	6 50%	1 25%	2 50%	1 33.3%	10 43.5%
Not Hispanic or Latino	6 50%	3 75%	2 50%	2 66.7%	13 56.5%

Outcome Measures

1. Primary Outcome

Title	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)
Description	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.
Time Frame	Every 2 hours from 12 to 96 hours postsurgery

Outcome Measure Data

Analysis Population Description

Modified Intent-to-treat (mITT) population included all randomized and treated participants with at least one post-injection pain score.

Arm/Group Title	Placebo	Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E Dose 3
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Measure Participants	11	1	4	3
Mean (Standard Deviation) [hour (hr)*score on a scale]	321.18 (217.993)	209.30 (NA)	415.40 (124.101)	372.53 (135.799)

2. Secondary Outcome

Title	AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery
Description	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.
Time Frame	Every 2 hours from 0 to 96 hours postsurgery

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least one post-injection pain score.

Arm/Group Title	Placebo	Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E Dose 3
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Measure Participants	11	1	4	3
Mean (Standard Deviation) [hr*score on a scale]	403.80 (229.152)	282.50 (NA)	506.83 (130.598)	450.97 (139.769)

3. Secondary Outcome

Title	AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72)
Description	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.
Time Frame	Every 2 hours from 0 to 72 hours postsurgery

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least one post-injection pain score.

Arm/Group Title	Placebo	Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E Dose 3
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Measure Participants	11	1	4	3
Mean (Standard Deviation) [hr*score on a scale]	338.91 (173.785)	280.50 (NA)	416.70 (97.464)	372.47 (86.226)

4. Secondary Outcome

Title	AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48)
Description	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.
Time Frame	Every 2 hours from 0 to 48 hours postsurgery

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least one post-injection pain score.

Arm/Group Title	Placebo	Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E Dose 3
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Measure Participants	11	1	4	3
Mean (Standard Deviation) [hr*score on a scale]	253.53 (106.862)	240.80 (NA)	283.20 (60.450)	274.47 (32.686)

5. Secondary Outcome

Title	AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24)
Description	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.
Time Frame	Every 2 hours from 0 to 24 hours postsurgery

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least one post-injection pain score.

Arm/Group Title	Placebo	Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E Dose 3
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Measure Participants	11	1	4	3
Mean (Standard Deviation) [hr*score on a scale]	144.49 (46.693)	149.80 (NA)	155.53 (28.726)	146.30 (21.717)

6. Secondary Outcome

Title	AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24)
Description	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.
Time Frame	Every 2 hours from 12 to 24 hours postsurgery

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least one post-injection pain score.

Arm/Group Title	Placebo	Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E Dose 3
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Measure Participants	11	1	4	3
Mean (Standard Deviation) [hr*score on a scale]	61.91 (32.210)	76.60 (NA)	64.10 (22.825)	67.83 (18.827)

7. Secondary Outcome

Title	Participants Overall Assessment of Pain Using the NPRS After Discharge
Description	The participant assessed their pain after discharge using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable.
Time Frame	Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least one post-injection pain score.

Arm/Group Title	Placebo	Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E Dose 3
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Measure Participants	11	1	4	3
Day 6	2.3 (1.66)	0.0 (NA)	6.0 (1.83)	2.3 (2.08)
Day 7	2.3 (2.78)	0.0 (NA)	3.8 (0.50)	3.0 (3.00)
Day 8	1.8 (1.79)	0.0 (NA)	3.5 (1.73)	3.0 (3.00)
Day 9	2.1 (2.62)	0.0 (NA)	5.3 (1.50)	1.5 (2.12)
Day 10	1.8 (1.92)	0.0 (NA)	4.0 (0.82)	1.5 (2.12)
Day 11	1.8 (2.28)	0.0 (NA)	3.3 (1.50)	1.5 (2.12)
Day 12	1.7 (1.87)	0.0 (NA)	2.5 (1.29)	1.5 (2.12)
Day 13	1.7 (1.73)	0.0 (NA)	3.0 (0.00)	2.0 (2.83)
Day 14	1.7 (1.94)	0.0 (NA)	2.3 (1.71)	2.0 (2.83)
Day 16	1.9 (2.47)	0.0 (NA)	2.0 (0.82)	1.5 (2.12)
Day 18	1.6 (2.26)	0.0 (NA)	1.8 (0.96)	1.5 (2.12)
Day 20	1.6 (2.20)	0.0 (NA)	1.8 (0.96)	1.5 (2.12)
Day 22	1.1 (1.73)	0.0 (NA)	1.0 (1.41)	1.5 (2.12)
Day 24	1.5 (2.45)	0.0 (NA)	1.0 (1.41)	2.0 (2.83)
Day 26	1.3 (1.98)	0.0 (NA)	1.0 (1.41)	1.5 (2.12)

8. Secondary Outcome

Title	Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A)
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least one post-injection pain score. Participants analyzed is the number of participants with data available for analysis at the given time point.

Arm/Group Title	Placebo	Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E Dose 3
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Measure Participants	11	1	4	3
8 hours after surgery	6.9 (2.74)	5.0 (NA)	6.0 (2.45)	6.3 (0.58)
16 hours after surgery	8.7 (1.53)	4.0 (NA)	7.0 (NA)
24 hours after surgery	6.6 (2.40)	5.0 (NA)	7.5 (1.29)	6.3 (0.58)
30 hours after surgery	6.5 (2.45)	5.0 (NA)	7.0 (2.16)	5.0 (2.00)
36 hours after surgery	6.3 (1.89)	4.0 (NA)	6.5 (1.29)	6.3 (0.58)
42 hours after surgery	5.8 (1.47)
48 hours after surgery	4.3 (1.50)	3.0 (NA)	5.3 (1.71)	3.7 (1.53)
54 hours after surgery	4.8 (1.20)	2.0 (NA)	6.3 (3.10)	4.0 (2.00)
60 hours after surgery	6.3 (2.75)	3.0 (NA)	6.0 (1.41)	3.3 (2.52)
66 hours after surgery	4.7 (3.20)
72 hours after surgery	3.7 (2.45)	0.0 (NA)	4.0 (2.71)	3.0 (1.73)
78 hours after surgery	3.6 (2.62)	0.0 (NA)	4.5 (2.08)	3.3 (2.08)
84 hours after surgery	4.5 (3.32)	1.0 (NA)	5.0 (1.15)	3.0 (2.65)
96 hours after surgery	2.4 (1.81)	0.0 (NA)	3.5 (1.29)	3.3 (3.06)
Day 8 after discharge	2.1 (2.20)	1.0 (NA)	4.8 (1.71)	3.3 (3.06)
Day 15 after discharge	1.6 (1.77)	0.0 (NA)	3.8 (2.99)	2.7 (2.31)
Day 29 after discharge	1.5 (1.97)	0.5 (0.58)	0.0 (NA)

9. Secondary Outcome

Title	Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories
Description	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.
Time Frame	Days 5, 8, 15 and 29

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least one post-injection pain score.

Arm/Group Title	Placebo	Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E Dose 3
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Measure Participants	11	1	4	3
PGA score 3	7 58.3%	1 25%	2 50%	1 33.3%
PGA score 2	4 33.3%	0 0%	2 50%	1 33.3%
PGA score 1	0 0%	0 0%	0 0%	1 33.3%
PGA score 0	0 0%	0 0%	0 0%	0 0%
PGA score 3	7 58.3%	1 25%	0 0%	1 33.3%
PGA score 2	4 33.3%	0 0%	2 50%	0 0%
PGA score 1	0 0%	0 0%	1 25%	2 66.7%
PGA score 0	0 0%	0 0%	1 25%	0 0%
PGA score 3	8 66.7%	1 25%	2 50%	1 33.3%
PGA score 2	3 25%	0 0%	1 25%	1 33.3%
PGA score 1	0 0%	0 0%	1 25%	1 33.3%
PGA score 0	0 0%	0 0%	0 0%	0 0%
PGA score 3	9 75%	1 25%	3 75%	1 33.3%
PGA score 2	2 16.7%	0 0%	1 25%	2 66.7%
PGA score 1	0 0%	0 0%	0 0%	0 0%
PGA score 0	0 0%	0 0%	0 0%	0 0%

10. Secondary Outcome

Title	Number of Doses of Rescue Medications Used
Time Frame	Up to 96 hours postsurgery

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least one post-injection pain score.

Arm/Group Title	Placebo	Botulinum Neurotoxin Serotype E Dose 1	Botulinum Neurotoxin Serotype E Dose 2	Botulinum Neurotoxin Serotype E Dose 3
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Measure Participants	11	1	4	3
Oxycodone	9.7 (5.92)	5.0 (NA)	11.8 (5.68)	11.7 (4.93)
Opioid	14.2 (7.40)	8.0 (NA)	15.8 (6.90)	16.0 (6.08)

Adverse Events

Time Frame	Up to 31 days
Adverse Event Reporting Description	Safety Population included all participants exposed to any amount of study drug.
Arm/Group Title	Placebo		Botulinum Neurotoxin Serotype E Dose 1		Botulinum Neurotoxin Serotype E Dose 2		Botulinum Neurotoxin Serotype E Dose 3
Arm/Group Description	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.		Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.		Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.		Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
All Cause Mortality
	Placebo		Botulinum Neurotoxin Serotype E Dose 1		Botulinum Neurotoxin Serotype E Dose 2		Botulinum Neurotoxin Serotype E Dose 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/4 (0%)		0/4 (0%)		0/3 (0%)
Serious Adverse Events
	Placebo		Botulinum Neurotoxin Serotype E Dose 1		Botulinum Neurotoxin Serotype E Dose 2		Botulinum Neurotoxin Serotype E Dose 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/4 (0%)		0/4 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Botulinum Neurotoxin Serotype E Dose 1		Botulinum Neurotoxin Serotype E Dose 2		Botulinum Neurotoxin Serotype E Dose 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/12 (66.7%)		3/4 (75%)		4/4 (100%)		3/3 (100%)
Gastrointestinal disorders
Nausea	6/12 (50%)		1/4 (25%)		2/4 (50%)		2/3 (66.7%)
Constipation	2/12 (16.7%)		1/4 (25%)		2/4 (50%)		0/3 (0%)
Vomiting	1/12 (8.3%)		1/4 (25%)		1/4 (25%)		0/3 (0%)
Dyspepsia	0/12 (0%)		0/4 (0%)		1/4 (25%)		0/3 (0%)
Immune system disorders
Food allergy	1/12 (8.3%)		0/4 (0%)		0/4 (0%)		0/3 (0%)
Infections and infestations
Tooth infection	1/12 (8.3%)		0/4 (0%)		0/4 (0%)		0/3 (0%)
Injury, poisoning and procedural complications
Seroma	0/12 (0%)		0/4 (0%)		1/4 (25%)		0/3 (0%)
Investigations
Transaminases increased	0/12 (0%)		1/4 (25%)		0/4 (0%)		0/3 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/12 (8.3%)		0/4 (0%)		2/4 (50%)		0/3 (0%)
Nervous system disorders
Headache	5/12 (41.7%)		1/4 (25%)		1/4 (25%)		0/3 (0%)
Psychiatric disorders
Depressed mood	0/12 (0%)		1/4 (25%)		0/4 (0%)		0/3 (0%)
Reproductive system and breast disorders
Vaginal haemorrhage	0/12 (0%)		0/4 (0%)		1/4 (25%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/12 (8.3%)		0/4 (0%)		0/4 (0%)		2/3 (66.7%)
Skin and subcutaneous tissue disorders
Pruritus	0/12 (0%)		1/4 (25%)		1/4 (25%)		0/3 (0%)
Pruritus generalised	0/12 (0%)		1/4 (25%)		0/4 (0%)		0/3 (0%)
Rash	2/12 (16.7%)		0/4 (0%)		0/4 (0%)		1/3 (33.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.