Actively Recruiting
Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
Led by Rebel Medicine Inc · Updated on 2026-05-07
60
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at screening
- American Society of Anesthesiologists (ASA) physical status classification of 1, 2, or 3
- Able to give informed consent, follow the study plan, and complete all assessments
- Scheduled for primary unilateral distal metaphyseal osteotomy (Austin procedure) bunionectomy
- Surgery is elective and related to bunion deformity (hallux valgus)
- Body Mass Index (BMI) is 18 or greater and less than 40 kg/m2
You will not qualify if you...
- Allergy, intolerance or contraindication to study medications without alternatives (e.g., amide local anesthetics, opioids, bupivacaine HCl, NSAIDs)
- Painful conditions like arthritis, fibromyalgia, or cancer requiring pain medications that could affect study results
- Poor sensory function in foot or ankle
- History or suspicion of drug or alcohol abuse within past 2 years
- Use of investigational drugs within 30 days or five half-lives before study drug
- Use of local anesthetics within 72 hours before study drug, except pretreatment for needle placement
- Need for additional local anesthetics besides study drug or lidocaine during study
- Uncontrolled anxiety, psychiatric or neurological disorders interfering with study
- Pregnancy, nursing, or planning pregnancy during study
- Significant medical conditions making participation unsafe (e.g., diabetic neuropathy, bleeding disorders, severe vascular disease, kidney or liver impairment)
- Abnormal vital signs or ECG (QTcF > 450 msec) at screening
- Liver cirrhosis or elevated liver enzymes over 3 times normal
- Severe kidney impairment (eGFR < 30 mL/min/1.73 m2) or dialysis
- Low blood counts (platelets < 100,000/uL, hemoglobin < 12 g/dL, hematocrit < 35%)
- Current use of gabapentinoids or SNRIs with analgesic effects that cannot be stopped 30 days before surgery
- Use of systemic glucocorticoids within 30 days before randomization
- Use of dexmedetomidine or clonidine within 3 days before study drug
- Marijuana use within 30 days before randomization or planned use during study
- Chronic opioid use within 30 days before randomization (average ≥30 oral morphine mg equivalents/day)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CenExel Salt Lake City
Millcreek, Utah, United States, 84107
Actively Recruiting
Research Team
C
Caleb Lade, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here