Trial Outcomes & Findings for Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty (NCT NCT03429556)

Last Updated: 2019-08-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Every 2 hours from 12 to 96 hours postsurgery

Results posted on

2019-08-05

Participant Flow

Participant milestones

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

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into rectus abdominus (RA) muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 2 Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Overall Study Lost to Follow-up	0	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=12 Participants Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 n=4 Participants Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 2 n=4 Participants Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 n=3 Participants Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Total n=23 Participants Total of all reporting groups
Age, Continuous	36.5 years STANDARD_DEVIATION 5.2 • n=93 Participants	33.0 years STANDARD_DEVIATION 6.38 • n=4 Participants	36.3 years STANDARD_DEVIATION 7.72 • n=27 Participants	41.0 years STANDARD_DEVIATION 14.0 • n=483 Participants	36.7 years STANDARD_DEVIATION 3.29 • n=36 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants	3 Participants n=483 Participants	22 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	11 Participants n=36 Participants
Race/Ethnicity, Customized White or Caucasian	6 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	1 Participants n=483 Participants	10 Participants n=36 Participants
Race/Ethnicity, Customized Other/Mixed	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	1 Participants n=483 Participants	10 Participants n=36 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	6 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	13 Participants n=36 Participants

PRIMARY outcome

Timeframe: Every 2 hours from 12 to 96 hours postsurgery

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

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.

Outcome measures

Outcome measures
Measure	Botulinum Neurotoxin Serotype E Dose 2 n=4 Participants Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 n=3 Participants Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Placebo n=11 Participants Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 n=1 Participants Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
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)	415.40 hour (hr)*score on a scale Standard Deviation 124.101	372.53 hour (hr)*score on a scale Standard Deviation 135.799	321.18 hour (hr)*score on a scale Standard Deviation 217.993	209.30 hour (hr)*score on a scale Standard Deviation NA Standard deviation (SD) was not calculated for 1 participant.

SECONDARY outcome

Timeframe: Every 2 hours from 0 to 96 hours postsurgery

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

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.

Outcome measures

Outcome measures
Measure	Botulinum Neurotoxin Serotype E Dose 2 n=4 Participants Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 n=3 Participants Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Placebo n=11 Participants Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 n=1 Participants Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery	506.83 hr*score on a scale Standard Deviation 130.598	450.97 hr*score on a scale Standard Deviation 139.769	403.80 hr*score on a scale Standard Deviation 229.152	282.50 hr*score on a scale Standard Deviation NA SD was not calculated for 1 participant.

SECONDARY outcome

Timeframe: Every 2 hours from 0 to 72 hours postsurgery

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

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.

Outcome measures

Outcome measures
Measure	Botulinum Neurotoxin Serotype E Dose 2 n=4 Participants Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 n=3 Participants Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Placebo n=11 Participants Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 n=1 Participants Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72)	416.70 hr*score on a scale Standard Deviation 97.464	372.47 hr*score on a scale Standard Deviation 86.226	338.91 hr*score on a scale Standard Deviation 173.785	280.50 hr*score on a scale Standard Deviation NA SD was not calculated for 1 participant.

SECONDARY outcome

Timeframe: Every 2 hours from 0 to 48 hours postsurgery

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

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.

Outcome measures

Outcome measures
Measure	Botulinum Neurotoxin Serotype E Dose 2 n=4 Participants Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 n=3 Participants Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Placebo n=11 Participants Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 n=1 Participants Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48)	283.20 hr*score on a scale Standard Deviation 60.450	274.47 hr*score on a scale Standard Deviation 32.686	253.53 hr*score on a scale Standard Deviation 106.862	240.80 hr*score on a scale Standard Deviation NA SD was not calculated for 1 participant.

SECONDARY outcome

Timeframe: Every 2 hours from 0 to 24 hours postsurgery

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

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.

Outcome measures

Outcome measures
Measure	Botulinum Neurotoxin Serotype E Dose 2 n=4 Participants Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 n=3 Participants Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Placebo n=11 Participants Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 n=1 Participants Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24)	155.53 hr*score on a scale Standard Deviation 28.726	146.30 hr*score on a scale Standard Deviation 21.717	144.49 hr*score on a scale Standard Deviation 46.693	149.80 hr*score on a scale Standard Deviation NA The SD was not calculated due to less number of participants with data.

SECONDARY outcome

Timeframe: Every 2 hours from 12 to 24 hours postsurgery

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

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.

Outcome measures

Outcome measures
Measure	Botulinum Neurotoxin Serotype E Dose 2 n=4 Participants Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 n=3 Participants Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Placebo n=11 Participants Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 n=1 Participants Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24)	64.10 hr*score on a scale Standard Deviation 22.825	67.83 hr*score on a scale Standard Deviation 18.827	61.91 hr*score on a scale Standard Deviation 32.210	76.60 hr*score on a scale Standard Deviation NA SD was not calculated for 1 participant.

SECONDARY outcome

Timeframe: Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26

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

The participant assessed their pain after discharge using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable.

Outcome measures

Outcome measures
Measure	Botulinum Neurotoxin Serotype E Dose 2 n=4 Participants Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 n=3 Participants Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Placebo n=11 Participants Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 n=1 Participants Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 13	3.0 score on a scale Standard Deviation 0.00	2.0 score on a scale Standard Deviation 2.83	1.7 score on a scale Standard Deviation 1.73	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 14	2.3 score on a scale Standard Deviation 1.71	2.0 score on a scale Standard Deviation 2.83	1.7 score on a scale Standard Deviation 1.94	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 6	6.0 score on a scale Standard Deviation 1.83	2.3 score on a scale Standard Deviation 2.08	2.3 score on a scale Standard Deviation 1.66	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 7	3.8 score on a scale Standard Deviation 0.50	3.0 score on a scale Standard Deviation 3.00	2.3 score on a scale Standard Deviation 2.78	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 8	3.5 score on a scale Standard Deviation 1.73	3.0 score on a scale Standard Deviation 3.00	1.8 score on a scale Standard Deviation 1.79	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 9	5.3 score on a scale Standard Deviation 1.50	1.5 score on a scale Standard Deviation 2.12	2.1 score on a scale Standard Deviation 2.62	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 10	4.0 score on a scale Standard Deviation 0.82	1.5 score on a scale Standard Deviation 2.12	1.8 score on a scale Standard Deviation 1.92	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 11	3.3 score on a scale Standard Deviation 1.50	1.5 score on a scale Standard Deviation 2.12	1.8 score on a scale Standard Deviation 2.28	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 12	2.5 score on a scale Standard Deviation 1.29	1.5 score on a scale Standard Deviation 2.12	1.7 score on a scale Standard Deviation 1.87	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 16	2.0 score on a scale Standard Deviation 0.82	1.5 score on a scale Standard Deviation 2.12	1.9 score on a scale Standard Deviation 2.47	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 18	1.8 score on a scale Standard Deviation 0.96	1.5 score on a scale Standard Deviation 2.12	1.6 score on a scale Standard Deviation 2.26	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 20	1.8 score on a scale Standard Deviation 0.96	1.5 score on a scale Standard Deviation 2.12	1.6 score on a scale Standard Deviation 2.20	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 22	1.0 score on a scale Standard Deviation 1.41	1.5 score on a scale Standard Deviation 2.12	1.1 score on a scale Standard Deviation 1.73	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 24	1.0 score on a scale Standard Deviation 1.41	2.0 score on a scale Standard Deviation 2.83	1.5 score on a scale Standard Deviation 2.45	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participants Overall Assessment of Pain Using the NPRS After Discharge Day 26	1.0 score on a scale Standard Deviation 1.41	1.5 score on a scale Standard Deviation 2.12	1.3 score on a scale Standard Deviation 1.98	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Botulinum Neurotoxin Serotype E Dose 2 n=4 Participants Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 n=3 Participants Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Placebo n=11 Participants Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 n=1 Participants Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 16 hours after surgery	—	7.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.	8.7 score on a scale Standard Deviation 1.53	4.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) Day 29 after discharge	0.5 score on a scale Standard Deviation 0.58	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.	1.5 score on a scale Standard Deviation 1.97	—
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 8 hours after surgery	6.0 score on a scale Standard Deviation 2.45	6.3 score on a scale Standard Deviation 0.58	6.9 score on a scale Standard Deviation 2.74	5.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 24 hours after surgery	7.5 score on a scale Standard Deviation 1.29	6.3 score on a scale Standard Deviation 0.58	6.6 score on a scale Standard Deviation 2.40	5.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 30 hours after surgery	7.0 score on a scale Standard Deviation 2.16	5.0 score on a scale Standard Deviation 2.00	6.5 score on a scale Standard Deviation 2.45	5.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 36 hours after surgery	6.5 score on a scale Standard Deviation 1.29	6.3 score on a scale Standard Deviation 0.58	6.3 score on a scale Standard Deviation 1.89	4.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 42 hours after surgery	—	—	5.8 score on a scale Standard Deviation 1.47	—
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 48 hours after surgery	5.3 score on a scale Standard Deviation 1.71	3.7 score on a scale Standard Deviation 1.53	4.3 score on a scale Standard Deviation 1.50	3.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 54 hours after surgery	6.3 score on a scale Standard Deviation 3.10	4.0 score on a scale Standard Deviation 2.00	4.8 score on a scale Standard Deviation 1.20	2.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 60 hours after surgery	6.0 score on a scale Standard Deviation 1.41	3.3 score on a scale Standard Deviation 2.52	6.3 score on a scale Standard Deviation 2.75	3.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 66 hours after surgery	—	—	4.7 score on a scale Standard Deviation 3.20	—
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 72 hours after surgery	4.0 score on a scale Standard Deviation 2.71	3.0 score on a scale Standard Deviation 1.73	3.7 score on a scale Standard Deviation 2.45	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 78 hours after surgery	4.5 score on a scale Standard Deviation 2.08	3.3 score on a scale Standard Deviation 2.08	3.6 score on a scale Standard Deviation 2.62	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 84 hours after surgery	5.0 score on a scale Standard Deviation 1.15	3.0 score on a scale Standard Deviation 2.65	4.5 score on a scale Standard Deviation 3.32	1.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) 96 hours after surgery	3.5 score on a scale Standard Deviation 1.29	3.3 score on a scale Standard Deviation 3.06	2.4 score on a scale Standard Deviation 1.81	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) Day 8 after discharge	4.8 score on a scale Standard Deviation 1.71	3.3 score on a scale Standard Deviation 3.06	2.1 score on a scale Standard Deviation 2.20	1.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A) Day 15 after discharge	3.8 score on a scale Standard Deviation 2.99	2.7 score on a scale Standard Deviation 2.31	1.6 score on a scale Standard Deviation 1.77	0.0 score on a scale Standard Deviation NA SD was not calculated for 1 participant.

SECONDARY outcome

Timeframe: Days 5, 8, 15 and 29

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

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.

Outcome measures

Outcome measures
Measure	Botulinum Neurotoxin Serotype E Dose 2 n=4 Participants Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 n=3 Participants Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Placebo n=11 Participants Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 n=1 Participants Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 5 · PGA score 2	2 Participants	1 Participants	4 Participants	0 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 15 · PGA score 3	2 Participants	1 Participants	8 Participants	1 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 15 · PGA score 0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 29 · PGA score 3	3 Participants	1 Participants	9 Participants	1 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 5 · PGA score 3	2 Participants	1 Participants	7 Participants	1 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 5 · PGA score 1	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 5 · PGA score 0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 8 · PGA score 3	0 Participants	1 Participants	7 Participants	1 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 8 · PGA score 2	2 Participants	0 Participants	4 Participants	0 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 8 · PGA score 1	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 8 · PGA score 0	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 15 · PGA score 2	1 Participants	1 Participants	3 Participants	0 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 15 · PGA score 1	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 29 · PGA score 2	1 Participants	2 Participants	2 Participants	0 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 29 · PGA score 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories Day 29 · PGA score 0	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 96 hours postsurgery

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

Outcome measures

Outcome measures
Measure	Botulinum Neurotoxin Serotype E Dose 2 n=4 Participants Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 n=3 Participants Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.	Placebo n=11 Participants Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 n=1 Participants Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
Number of Doses of Rescue Medications Used Oxycodone	11.8 doses Standard Deviation 5.68	11.7 doses Standard Deviation 4.93	9.7 doses Standard Deviation 5.92	5.0 doses Standard Deviation NA SD was not calculated for 1 participant.
Number of Doses of Rescue Medications Used Opioid	15.8 doses Standard Deviation 6.90	16.0 doses Standard Deviation 6.08	14.2 doses Standard Deviation 7.40	8.0 doses Standard Deviation NA SD was not calculated for 1 participant.

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Botulinum Neurotoxin Serotype E Dose 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Botulinum Neurotoxin Serotype E Dose 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Botulinum Neurotoxin Serotype E Dose 3

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=12 participants at risk Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 1 n=4 participants at risk Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 2 n=4 participants at risk Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.	Botulinum Neurotoxin Serotype E Dose 3 n=3 participants at risk Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Gastrointestinal disorders Nausea	50.0% 6/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	50.0% 2/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	66.7% 2/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Gastrointestinal disorders Constipation	16.7% 2/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	50.0% 2/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Skin and subcutaneous tissue disorders Rash	16.7% 2/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	33.3% 1/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Musculoskeletal and connective tissue disorders Back pain	8.3% 1/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	50.0% 2/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Nervous system disorders Headache	41.7% 5/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	8.3% 1/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	66.7% 2/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Injury, poisoning and procedural complications Seroma	0.00% 0/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Investigations Transaminases increased	0.00% 0/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Psychiatric disorders Depressed mood	0.00% 0/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	25.0% 1/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Immune system disorders Food allergy	8.3% 1/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.
Infections and infestations Tooth infection	8.3% 1/12 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/4 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.	0.00% 0/3 • Up to 31 days Safety Population included all participants exposed to any amount of study drug.