Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Mastectomy in Patients With High PCS Scores

NCT04104919 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: ADYX-0061UG3DA048375-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multiple center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with high Pain Catastrophizing Scale (PCS) scores undergoing mastectomy with immediate tissue expander or implant placement.

Conditions

Pain, Postoperative

Keywords

Mastectomy

Outcome Measures

Primary Outcomes (1)

• Pain with general movement involving the chest and upper body

  Least Squares (LS) Mean pain rating with general movement involving the chest and upper body on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)

  Day 3 to Day 14

Secondary Outcomes (6)

• Pain at rest

  Day 3 to Day 14

• Pain with deep full inspiration and forceful effective cough

  Day 3 to Day 14

• Pain with ipsilateral arm abduction

  Day 14 to Day 21

• Total use of postoperative opioid medications

  Day 3 to Day 14

• Total use of postoperative opioid medications

  Day 1 through Day 21

Study Arms (2)

Brivoligide Injection 660 mg/6 mL

EXPERIMENTAL

Subjects randomized to the brivoligide treatment group will receive a single 660 mg/6 mL intrathecal administration of brivoligide injection while in the lateral decubitus position at lumbar interspace L3/4 or higher. After injection subjects will be placed supine in a 15-degree head down tilt (Trendelenburg position) for 5 minutes and then returned to supine horizontal for surgery.

Drug: Brivoligide Injection 660 mg/6 mL

Placebo 6 mL

PLACEBO COMPARATOR

Subjects randomized to the placebo group will receive a single 6 mL intrathecal administration of placebo while in the lateral decubitus position at lumbar interspace L3/4 or higher. After injection subjects will be placed supine in a 15-degree head down tilt (Trendelenburg position) for 5 minutes and then returned to supine horizontal for surgery.

Drug: Placebo 6 mL

Interventions

Brivoligide Injection 660 mg/6 mL DRUG

Single preoperative intrathecal injection

Also known as: AYX1 Injection 660 mg/6 mL

Brivoligide Injection 660 mg/6 mL

Placebo 6 mL DRUG

Single preoperative intrathecal injection

Placebo 6 mL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Score of 16 or greater on the PCS scale
• Scheduled to undergo unilateral or bilateral mastectomy with immediate tissue expander or implant placement
• American Society of Anesthesiologists Physical Status Classification System ≤ 3
• Medically stable for this surgery with general anesthesia and intrathecal administration of study drug as determined by the Investigator
• Body mass index of 18-45 kg/m2
• Have a stable medical regimen (for prescribed medications) for ≥ 7 days before randomization
• Able to read and understand study instructions in English or Spanish, and willing and able to comply with all study procedures

You may not qualify if:

• Prior breast surgery in the index breast (either breast for bilateral surgery) in the last two years, other than biopsies and small/moderate volume lumpectomies
• Induction chemotherapy or plans for adjunctive chemotherapy or any radiotherapy within 21 days of surgery
• Known spinal deformities or cutaneous infection in the lumbar area that would preclude intrathecal administration of study drug
• Planned use of liposomal formulated or long-acting local anesthetics, extended release opioid formulations (e.g., Oxycontin), long half-life opioids (e.g., methadone), or drugs with potential for adverse cognitive or memory effects (e.g., ketamine, scopolamine, or propranolol) preoperatively and/or at any time through the duration of the study
• Use of more than 40 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization
• Current neurologic disorder, which could confound the assessment of pain
• Unstable mental condition which would prevent the patient from understanding the nature and scope of the study and/or evidence of an uncooperative attitude in the opinion of the Investigator
• Women who are pregnant or nursing
• Participation in a clinical trial with the last dose or intervention within 1 month of randomization, or planned treatment in a clinical trial during this study
• Previous participation in any study involving brivoligide injection

Sponsors & Collaborators

• Adynxx, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share