Sciatic Nerve Block with ALX006 for Bunionectomy Pain
This study is testing a new, extended-release pain medication called ALX006. It's being compared to a standard pain medication, Bupivacaine HCl 0.25% Injection, given as a sciatic nerve block (an injection near the nerve in your leg to numb the area) for people having bunion surgery. Researchers want to see how safe ALX006 is and how well it works to control pain. About 60 adults, aged 18 and older, who are having bunion surgery can join. The main goal is to track any side effects from the nerve block for about 15 days after the procedure. This study is currently unclear on its recruitment status.
- Study design
- This is a Phase 2, randomized, double-blind study involving about 60 participants. It compares different doses of ALX006 to a standard pain medication.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for side effects from the nerve block for up to 15 days after the procedure.
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NCT07574385
Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
Recruiting
PHASE2Ages 18+InterventionalTreatmentRebel Medicine Inc
~60 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:ALX006 (bupivacaine extended-release injection)Bupivacaine Hcl 0.25% InjSciatic Nerve Block
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured over From start of nerve block procedure through 360 Hour Visit (Day 15)
Conditions
Where it's being run
1 sites across 1 statesUtah1
Study leadership
- Jayant Agarwal, MD · STUDY_DIRECTOR · Rebel Medicine Inc
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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):
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)
What this trial measures
- Incidence and severity of treatment-emergent adverse events (TEAEs)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