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

NCT ID: NCT03429556

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-08
• Study Completion Date: 2018-07-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into 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.

Group Type: EXPERIMENTAL

Botulinum Neurotoxin Serotype E

Intervention Type: BIOLOGICAL

Single botulinum neurotoxin serotype E 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.

Group Type: EXPERIMENTAL

Botulinum Neurotoxin Serotype E

Intervention Type: BIOLOGICAL

Single botulinum neurotoxin serotype E 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.

Group Type: EXPERIMENTAL

Botulinum Neurotoxin Serotype E

Intervention Type: BIOLOGICAL

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

Interventions

Botulinum Neurotoxin Serotype E

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

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: DRUG

Other Intervention Names

EB-001; BoNT/E

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.

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan-En Lin

Role: STUDY_DIRECTOR

Allergan

Locations

Huntington Ambulatory Surgery Center

Pasadena, California, United States

Lotus Clinical Research, LLC

Pasadena, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

EB001-ABD201

Identifier Type: -

Identifier Source: org_study_id