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New treatment option for Hallux Valgus
Official title Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
ClinicalTrials.gov ID: NCT07574385
What this study is testing
What is ALX006 (bupivacaine extended-release injection)?
ALX006 (bupivacaine extended-release injection) is an investigational medicine, being studied as a potential treatment for hallux valgus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Indicated to undergo elective (i.e., not emergency) bunionectomy
You likely can't join if
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol...
- Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post...
- 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...
- Administration of any local anesthetic within 72 hours prior to administration of study drug, other than for pretreatment prior to a needle placement
See the full eligibility 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
- 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...
- 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...
- 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...
- 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):
- History of liver cirrhosis, having an aspartate aminotransferase \>3x the upper limit of normal (ULN), or having an alanine aminotransferase \> 3x ULN.
- 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.
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Millcreek, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Millcreek, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.