Clinical trial NCT03429556: Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Abdominoplasty
Keywords: pain, neurotoxin
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-02-12
Enrollment: 23
Sex: ALL
Minimum age (years): 23
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Every 2 hours from 12 to 96 hours postsurgery
Secondary outcomes:
measure: AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery
timeFrame: Every 2 hours from 0 to 96 hours postsurgery
measure: AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72)
timeFrame: Every 2 hours from 0 to 72 hours postsurgery
measure: AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48)
timeFrame: Every 2 hours from 0 to 48 hours postsurgery
measure: AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24)
timeFrame: Every 2 hours from 0 to 24 hours postsurgery
measure: AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24)
timeFrame: Every 2 hours from 12 to 24 hours postsurgery
measure: Participants Overall Assessment of Pain Using the NPRS After Discharge
timeFrame: Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26
measure: Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A)
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
measure: Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories
timeFrame: Days 5, 8, 15 and 29
measure: Number of Doses of Rescue Medications Used
timeFrame: Up to 96 hours postsurgery
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Huntington Ambulatory Surgery Center
state: California
city: Pasadena
country: United States
facility: Lotus Clinical Research, LLC
state: California
Study officials:
affiliation: Allergan
name: Joan-En Lin
role: STUDY_DIRECTOR
References: