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

A Phase 2 study testing Brivoligide Injection 660 mg/6 mL in people with Pain, Postoperative, run by Adynxx, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years, women only
Conditions the study is for: Pain, Postoperative
What is being tested?: Brivoligide Injection 660 mg/6 mL
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Jan 2021to Feb 2022
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

About this study

Official title: A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of Brivoligide Injection in Patients With a Pain Catastrophizing Scale Score ≥16 Undergoing Mastectomy With Immediate Tissue Expander or Implant Placement

Read the detailed description

Potential subjects will be prescreened for PCS score; pre-qualified patients will be invited to the investigative site for informed consent and full screening within 30 days of randomization. Patients providing informed consent and meeting all study eligibility criteria will be enrolled in the study on the day of surgery (Day 1).

Subjects will receive study drug just prior to anesthesia induction. Study assessments will be entered by subjects in the electronic diary from Day 1 through Day 21. Follow-up visits will occur on Days 7 and 21 (± 2 days).

Conditions: Pain, Postoperative
Being tested: Brivoligide Injection 660 mg/6 mL, Placebo 6 mL
Keywords: Mastectomy
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brivoligide Injection 660 mg/6 mLDrug
Also called AYX1 Injection 660 mg/6 mL
Single preoperative intrathecal injection
Placebo 6 mLDrug
Single preoperative intrathecal injection

Study groups in NCT04104919
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Placebo 6 mL

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Day 3 to Day 14

Secondary outcomes (6)

Pain at rest
Least Squares (LS) Mean pain rating at rest on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
Measured: Day 3 to Day 14
Pain with deep full inspiration and forceful effective cough
Least Squares (LS) Mean pain rating with deep full inspiration and forceful effective cough on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
Measured: Day 3 to Day 14
Pain with ipsilateral arm abduction
Least Squares (LS) Mean pain rating with ipsilateral arm abduction on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
Measured: Day 14 to Day 21
Total use of postoperative opioid medications
Total use (median) of postoperative opioid medications (morphine equivalents)
Measured: Day 3 to Day 14
Total use of postoperative opioid medications
Total use (median) of postoperative opioid medications (morphine equivalents)
Measured: Day 1 through Day 21
Change from baseline for the BREAST-Q
Change from baseline to Day 21 for the BREAST-Q
Measured: Screening to Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2021Feb 2022

First posted26 Sep 2019
Study startJan 2021 (estimated)
Primary completionJan 2022 (estimated)
Study completionFeb 2022 (estimated)

Why it stopped: Study Initiation delayed due to COVID 19

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04104919
Sponsor's protocol ID: ADYX-006
Other IDs: 1UG3DA048375-01
Status last verified: Jul 2020
First submitted: 24 Sep 2019
Last updated: 13 Jul 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pain, Postoperative trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of Brivoligide Injection in Patients With a Pain Catastrophizing Scale Score ≥16 Undergoing Mastectomy With Immediate Tissue Expander or Implant Placement
ClinicalTrials.gov ID: NCT04104919
Acronym / sponsor ID: ADYX-006
Conditions: Pain, Postoperative
Keywords: Mastectomy
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Study Initiation delayed due to COVID 19
Enrolment: 0 participants (actual)
Lead sponsor: Adynxx, Inc.Industry (pharma, biotech, devices)
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Jan 2021 (estimated)
Primary completion: Jan 2022 (estimated)
Study completion: Feb 2022 (estimated)
First posted: 26 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Brivoligide Injection 660 mg/6 mL	Experimental	Drug: Brivoligide Injection 660 mg/6 mLSubjects 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.
Placebo 6 mL	Placebo comparator	Drug: Placebo 6 mLSubjects 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.

Who may qualify

Ages: 18 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Brivoligide Injection 660 mg/6 mLAlso: AYX1 Injection 660 mg/6 mLSingle preoperative intrathecal injection	Drug	Brivoligide Injection 660 mg/6 mL
Placebo 6 mLSingle preoperative intrathecal injection	Drug	Placebo 6 mL

Primary outcome

Pain with general movement involving the chest and upper body
Time frame: Day 3 to Day 14
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)

6 secondary outcomes

Pain at rest
Time frame: Day 3 to Day 14
Pain with deep full inspiration and forceful effective cough
Time frame: Day 3 to Day 14
Pain with ipsilateral arm abduction
Time frame: Day 14 to Day 21
Total use of postoperative opioid medications
Time frame: Day 3 to Day 14
Total use of postoperative opioid medications
Time frame: Day 1 through Day 21
Change from baseline for the BREAST-Q
Time frame: Screening to Day 21

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
Individual participant dataSharing planned: No

Related trials for Pain, Postoperative

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
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Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
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Active, not recruitingPhase 4
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Cesarean Section

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brivoligide Injection 660 mg/6 mL in people with Pain, Postoperative, run by Adynxx, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain with general movement involving the chest and upper body (time frame: Day 3 to Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04104919.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.