Study to Evaluate EB-001 in Reducing Musculoskeletal Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Musculoskeletal Pain

In brief

To determine the safety and efficacy of single intra-operative treatment of EB-001 IM injections into the Pectoralis Major (PM) in subjects undergoing breast augmentation with subpectoral implants

Key facts

Study ID

NCT03193593

Run by

Bonti, Inc.

People needed

66

Starts

2017-08-29

Expected to finish

2018-08-07

Last updated by the study team

2019-01-25

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women 18 to 55 years of age, inclusive
• Women who are in good health as determined by medical history, physical examination, clinical laboratory studies, ECGs, vital signs, and Investigator judgment
• Scheduled to undergo primary breast augmentation under general anesthesia (endotracheal or otherwise) with:
• Sub-pectoral implants placement,
• Infra-mammary surgical approach,
• Implant size between 250 and 400cc and
• Non-textured saline breast implants
• American Society of Anesthesiologist (ASA) Physical Class 1-2
• Women of non-childbearing potential or postmenopausal (at least 12 consecutive months of amenorrhea)
• Women of childbearing potential must not be pregnant, lactating, or planning to become pregnant during the study
• Women of childbearing potential agreeing to use either:
• a highly effective method of contraception with failures rates less than 1% per year such as implant, intrauterine device (IUD), or confirmed sterilization and sterilization procedure at least 3 months prior to the day of dosing
• dual methods of contraception with overall failures rate less than 1% per year such as injectable, pill, patch, ring, and diaphragm from the day of dosing for 3 months (subjects using oral contraception must have initiated treatment at least 2 months prior to the day of dosing)
• Willing and able to complete protocol requirements and instructions, which includes completion of all required visits, procedures and in-clinic stays until the end of the study
• Willing and able to sign and date IRB-approved informed consent
• Able to speak, read, and understand the language of the informed consent form (ICF) and study questionnaires

You may not qualify if…

• History of surgical procedure involving the breast, including, but not limited to, breast augmentation. History of minor localized breast biopsy is not exclusionary if it occurred at least 1 year prior to the screening visit, and if considered not clinically significant in the opinion of the investigator.
• Pre-existing lung disease that could impact subject safety in the opinion of the investigator
• History of smoking within the past two years
• Slow vital capacity that is below 80% of normal value for respective race, age, height, and gender
• Pulse oximetry below 95%
• Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32
• Documented diagnosis of chronic pain condition, or other painful pre-operative condition that, in the opinion of the investigator, may require analgesic treatment in the post-operative period (e.g. significant joint pain, neuropathic pain)
• Known hypersensitivity to any botulinum toxin serotype or to any component of the formulation
• Reported use of any botulinum toxin within 3 months prior to the date of surgery
• Anticipated use of any botulinum toxin of any serotype during the study
• 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
• Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis)
• Any past or current medical condition that in opinion of investigator, puts subject at undue safety risk for surgical complications or for use of the investigational product.
• Any clinically significant psychiatric condition that, in opinion of investigator, may interfere with study assessments or protocol compliance
• History of alcohol or drug abuse in the last 3 years, based on investigator judgement
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days or 5 half-lives of the drug, whichever is longer, of entry into this study
• Subject plans to donate blood or plasma from 30 days prior to screening until last follow-up visit (Day 29)
• Reported pain score of 2 or more at screening on the 11-point scale NPRS-A following strength testing with PM activation

Where it is running

• Lotus Clinical Research — Pasadena, California, United States

Full record on ClinicalTrials.gov

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