Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy

May 4, 2026 updated by: Rebel Medicine Inc

A Phase 2, Randomized, Double-blind, Active-controlled, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, Efficacy and Pharmacodynamics of ALX006 for Postsurgical Pain Management When Administered as a Sciatic (in the Popliteal Fossa) Nerve Block in Subjects Undergoing a Bunionectomy

This is a Phase 2, randomized, double-blind, active-controlled, dose-escalation study evaluating the safety, pharmacokinetics, efficacy, and pharmacodynamics of ALX006, an extended-release bupivacaine formulation, administered as a single-dose sciatic nerve block in the popliteal fossa in adult subjects undergoing primary unilateral bunionectomy. Approximately 60 subjects will be enrolled across 3 sequential dose cohorts (100 mg, 150 mg, 200 mg ALX006), with each cohort comparing ALX006 against MARCAINE 0.25% (bupivacaine HCl 50 mg) as the active comparator at a 3:1 randomization ratio. Dose escalation between cohorts is governed by an Independent Data Monitoring Committee.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Utah
      • Millcreek, Utah, United States, 84107
        • Recruiting
        • CenExel Salt Lake City
        • Principal Investigator:
          • Todd Bertoch, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female, ages 18 or older at screening
  • American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 (see Appendix 5)
  • Able to provide informed consent, adhere to the study schedule, and complete all study assessments
  • Primary surgical indication is related to a bunion deformity (i.e., hallux valgus) and subject is scheduled to undergo a primary unilateral distal metaphyseal osteotomy procedure (i.e., Austin procedure)
  • Indicated to undergo elective (i.e., not emergency) bunionectomy
  • Body Mass Index (BMI) ≥18 and <40 kg/m2

Exclusion Criteria:

  • Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
  • Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the surgery and which, in the Investigator's opinion, may confound the post dosing assessments
  • Inadequate sensory function of the foot/ankle as assessed by the Investigator
  • History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two (2) years
  • Administration of an investigational drug within thirty (30) days or five (5) elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
  • Administration of any local anesthetic within 72 hours prior to administration of study drug, other than for pretreatment prior to a needle placement
  • Require additional local anesthetic other than study drug or lidocaine used for the Mayo field block or for pretreatment prior to a needle placement during the study period
  • Uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
  • Currently pregnant, nursing, or planning to become pregnant during the study
  • Clinically significant medical disease that, in the opinion of the Investigator would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction, glucose-6-phosphate dehydrogenase deficiency or other conditions that would constitute a contraindication to participation in the study
  • Confirmed clinically significant vital sign or ECG abnormality, including QTcF > 450 msec at Screening

  • Has any of the following laboratory abnormalities during Screening (1 retest permitted):

    1. History of liver cirrhosis, having an aspartate aminotransferase >3x the upper limit of normal (ULN), or having an alanine aminotransferase > 3x ULN.
    2. Severe kidney function impairment as defined by estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation <30 mL/min/1.73 m²or on dialysis.
    3. Platelet count < 100,000/uL, hemoglobin < 12 g/dL, or hematocrit < 35%.
  • Currently on a gabapentinoid (e.g., gabapentin, pregabalin [Lyrica]) or a serotonin-norepinephrine reuptake inhibitor (SNRI) with recognized analgesic properties (e.g., duloxetine [Cymbalta]) that cannot be discontinued within 30 days before surgery. Other agents with documented efficacy in modulating acute or chronic pain may be excluded at the discretion of the Investigator in consultation with the Sponsor Medical Monitor. Selective serotonin reuptake inhibitors (SSRIs) are not excluded under this criterion.
  • Current use of systemic glucocorticoids within thirty (30) days of randomization in this study
  • Use of dexmedetomidine HCl or clonidine within three (3) days of study drug administration
  • Any use of marijuana (including tetrahydrocannabinol (THC) and cannabidiol (CBD)) within thirty (30) days prior to randomization, or planned use during the study.
  • Chronic opioid use within thirty (30) days prior to randomization (average ≥30 oral morphine mg equivalents/day)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ALX006 100 mg
Single-dose ALX006 100 mg (50 mg/mL bupivacaine free base) administered as ultrasound-guided sciatic nerve block in the popliteal fossa, 60 min (±15 min) prior to bunionectomy.
Drug: ALX006 (bupivacaine extended-release injection)
ALX006 (50 mg/mL bupivacaine free base)
Procedure: Sciatic Nerve Block
Sciatic nerve block in the popliteal fossa
Other Names:
  • Sciatic Nerve Block in the Popliteal Fossa
Experimental: ALX006 150 mg
Single-dose ALX006 150 mg (50 mg/mL bupivacaine free base) administered as ultrasound-guided sciatic nerve block in the popliteal fossa, 60 min (±15 min) prior to bunionectomy.
Drug: ALX006 (bupivacaine extended-release injection)
ALX006 (50 mg/mL bupivacaine free base)
Procedure: Sciatic Nerve Block
Sciatic nerve block in the popliteal fossa
Other Names:
  • Sciatic Nerve Block in the Popliteal Fossa
Experimental: ALX006 200 mg
Single-dose ALX006 200 mg (50 mg/mL; bupivacaine free base) administered as ultrasound-guided sciatic nerve block in the popliteal fossa, 60 min (±15 min) prior to bunionectomy.
Drug: ALX006 (bupivacaine extended-release injection)
ALX006 (50 mg/mL bupivacaine free base)
Procedure: Sciatic Nerve Block
Sciatic nerve block in the popliteal fossa
Other Names:
  • Sciatic Nerve Block in the Popliteal Fossa
Active Comparator: MARCAINE 0.25%
Single-dose MARCAINE 0.25% (bupivacaine HCl 50 mg; 20 mL), administered as ultrasound-guided sciatic nerve block in the popliteal fossa, 60 min (±15 min) prior to bunionectomy.
Procedure: Sciatic Nerve Block
Sciatic nerve block in the popliteal fossa
Other Names:
  • Sciatic Nerve Block in the Popliteal Fossa
Drug: Bupivacaine Hcl 0.25% Inj
Bupivacaine HCl 0.25% plain (2.5 mg/mL)
Other Names:
  • MARCAINE 0.25%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time Frame: From start of nerve block procedure through 360 Hour Visit (Day 15)
TEAEs graded by CTCAE v5.0, summarized by System Organ Class and Preferred Term
From start of nerve block procedure through 360 Hour Visit (Day 15)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUC of NRS pain intensity scores 0-72 hours post-surgery
Time Frame: 0 to 72 hours post-surgery
Area under the curve of 11-point Numeric Rating Scale (0 = no pain; 10 = worst possible pain) for current pain in operative foot
0 to 72 hours post-surgery
AUC of NRS pain intensity scores 0-96 hours post-surgery
Time Frame: 0 to 96 hours post-surgery
Area under the curve of 11-point Numeric Rating Scale (0 = no pain; 10 = worst possible pain) for current pain in operative foot
0 to 96 hours post-surgery
AUC of NRS pain intensity scores 0-120 hours post-surgery
Time Frame: 0 to 120 hours post-surgery
Area under the curve of 11-point Numeric Rating Scale (0 = no pain; 10 = worst possible pain) for current pain in operative foot
0 to 120 hours post-surgery
Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 0 to 72 hours post-surgery
Time Frame: 0 to 72 hours post-surgery
Cumulative opioid consumption from the end of surgery through 72 hours, calculated as oral morphine equivalent dose (OMED) using CDC opioid morphine equivalent conversion factors.
0 to 72 hours post-surgery
Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 0 to 96 hours post-surgery
Time Frame: 0 to 96 hours post-surgery
Cumulative opioid consumption from the end of surgery through 96 hours, calculated as oral morphine equivalent dose (OMED) using CDC opioid morphine equivalent conversion factors.
0 to 96 hours post-surgery
Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 0 to 120 hours post-surgery
Time Frame: 0 to 120 hours post-surgery
Cumulative opioid consumption from the end of surgery through 120 hours, calculated as oral morphine equivalent dose (OMED) using CDC opioid morphine equivalent conversion factors.
0 to 120 hours post-surgery
Percentage of opioid-free subjects through 72 hours post-surgery
Time Frame: 0 to 72 hours post-surgery
Proportion of subjects who consumed no opioid medication from the end of surgery through 72 hours.
0 to 72 hours post-surgery
Percentage of opioid-free subjects through 96 hours post-surgery
Time Frame: 0 to 96 hours post-surgery
Proportion of subjects who consumed no opioid medication from the end of surgery through 96 hours.
0 to 96 hours post-surgery
Percentage of opioid-free subjects through 120 hours post-surgery
Time Frame: 0 to 120 hours post-surgery
Proportion of subjects who consumed no opioid medication from the end of surgery through 120 hours.
0 to 120 hours post-surgery
Median time to first postsurgical opioid consumption
Time Frame: End of surgery through 168 hours post-surgery
Time from end of surgery to administration of the first postsurgical opioid dose.
End of surgery through 168 hours post-surgery
Plasma bupivacaine maximum observed concentration (Cmax)
Time Frame: Pre-dose through 168 hours post-block administration
Maximum observed plasma bupivacaine concentration following single-dose administration
Pre-dose through 168 hours post-block administration
Time to maximum plasma bupivacaine concentration (Tmax)
Time Frame: Pre-dose through 168 hours post-block administration
Time from end of block administration to the maximum observed plasma bupivacaine concentration.
Pre-dose through 168 hours post-block administration
Apparent terminal elimination half-life of bupivacaine (t½el)
Time Frame: Pre-dose through 168 hours post-block administration
Apparent terminal elimination half-life of plasma bupivacaine
Pre-dose through 168 hours post-block administration
Apparent clearance of bupivacaine (CL/F)
Time Frame: Pre-dose through 168 hours post-block administration
Apparent clearance of bupivacaine following perineural administration, derived by non-compartmental analysis.
Pre-dose through 168 hours post-block administration

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Median time to onset of sensory block
Time Frame: From end of block administration through 168 hours
Median time from end of block administration to the earliest timepoint with loss of light touch sensation along the distribution of the target nerve distal to the block site
From end of block administration through 168 hours
Median duration of sensory block
Time Frame: From end of block administration through 168 hours
Median time between onset and offset of sensory block, where offset is defined as the first timepoint of return of light touch sensation in both test areas in a single assessment.
From end of block administration through 168 hours
Median time to onset of motor block
Time Frame: From end of block administration through 168 hours
Median time from end of block administration to the earliest timepoint with partial or no foot movement
From end of block administration through 168 hours
Median duration of motor block
Time Frame: From end of block administration through 168 hours
Median time between onset and offset of motor block, where offset is defined as resolution of motor block with complete foot movement (dorsiflexion and plantar flexion)
From end of block administration through 168 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rebel Medicine Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jayant Agarwal, MD, Rebel Medicine Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBL-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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