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

NCT03429556 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: EB001-ABD201
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Abdominoplasty

Keywords

pain, neurotoxin

Outcome Measures

Primary Outcomes (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)

  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 Outcomes (9)

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.

Drug: Placebo

Botulinum Neurotoxin Serotype E Dose 1

EXPERIMENTAL

Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.

Biological: Botulinum Neurotoxin Serotype E

Botulinum Neurotoxin Serotype E Dose 2

EXPERIMENTAL

Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.

Biological: Botulinum Neurotoxin Serotype E

Botulinum Neurotoxin Serotype E Dose 3

EXPERIMENTAL

Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.

Biological: Botulinum Neurotoxin Serotype E

Interventions

Botulinum Neurotoxin Serotype E BIOLOGICAL

Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.

Also known as: EB-001, BoNT/E

Botulinum Neurotoxin Serotype E Dose 1; Botulinum Neurotoxin Serotype E Dose 2; Botulinum Neurotoxin Serotype E Dose 3

Placebo DRUG

Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.

Placebo

Eligibility Criteria

• Age: 23 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women 23 to 55 years of age, inclusive
• 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
• American Society of Anesthesiologist (ASA) Physical Class 1-2.

You may not qualify if:

• History of prior major abdominal surgery as judged by the investigator
• Pre-existing lung disease that could impact participant safety in the opinion of the investigator
• Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis)
• At high risk of deep vein thrombosis as judged by the investigators determined by a Caprini score of 3 or higher
• 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
• Pulse oximetry below 95%
• Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32
• Reported use of any botulinum toxin within 3 months prior to the date of surgery
• Use of long acting opioids within 3 days or any opioid medication within 24 hours prior to surgery
• Aminoglycoside intake within 48 hours prior to or during surgery
• Participants on anti-depressant or anti-psychotic medications
• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Huntington Ambulatory Surgery Center

Pasadena, California, 91105, United States

Location

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Joan-En Lin

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 12, 2018
• Study Start: May 8, 2018
• Primary Completion: July 10, 2018
• Study Completion: July 10, 2018
• Last Updated: August 5, 2019
• Results First Posted: August 5, 2019

Record last verified: 2019-08

Locations

US (2)