NCT03429556

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 23 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum Neurotoxin Serotype E	Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.
DRUG	Placebo	Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.

Timeline

• Start date: 2018-05-08
• Primary completion: 2018-07-10
• Completion: 2018-07-10
• First posted: 2018-02-12
• Last updated: 2019-08-05
• Results posted: 2019-08-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study