Hallux ValgusPhase 2NCT07574385
Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
A Phase 2 study testing ALX006 (bupivacaine extended-release injection), Bupivacaine Hcl 0.25% Inj and Sciatic Nerve Block in people with Hallux Valgus and Bunionectomy, run by Rebel Medicine Inc at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus, Bunionectomy
- What is being tested?
- ALX006 (bupivacaine extended-release injection), Bupivacaine Hcl 0.25% Inj and Sciatic Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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):
- 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 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CenExel Salt Lake City
Millcreek, Utah, 84107
Director of Clinical Operations, (801) 261-2000, s.zunkowski@cenexel.com
Todd Bertoch, MD
About this study
Official title: 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.
- Conditions
- Hallux Valgus, Bunionectomy
- Being tested
- ALX006 (bupivacaine extended-release injection), Bupivacaine Hcl 0.25% Inj, Sciatic Nerve Block
- Keywords
- ALX006, Bupivacaine, Popliteal fossa nerve block, Analgesia, Post-operative analgesia
- Medical subject headings
- Hallux Valgus, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALX006 (bupivacaine extended-release injection)Drug
ALX006 (50 mg/mL bupivacaine free base)
Bupivacaine Hcl 0.25% InjDrug
Also called MARCAINE 0.25%
Bupivacaine HCl 0.25% plain (2.5 mg/mL)
Sciatic Nerve BlockProcedure or surgery
Also called Sciatic Nerve Block in the Popliteal Fossa
Sciatic nerve block in the popliteal fossa
| Study group | Role | What they receive |
|---|---|---|
| ALX006 100 mg | Experimental | 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. Receives: Drug: ALX006 (bupivacaine extended-release injection); Procedure: Sciatic Nerve Block |
| ALX006 150 mg | Experimental | 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. Receives: Drug: ALX006 (bupivacaine extended-release injection); Procedure: Sciatic Nerve Block |
| ALX006 200 mg | Experimental | 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. Receives: Drug: ALX006 (bupivacaine extended-release injection); Procedure: Sciatic Nerve Block |
| MARCAINE 0.25% | Active comparator | 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. Receives: Drug: Bupivacaine Hcl 0.25% Inj; Procedure: Sciatic Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
TEAEs graded by CTCAE v5.0, summarized by System Organ Class and Preferred Term
Measured: From start of nerve block procedure through 360 Hour Visit (Day 15)
Secondary outcomes (14)
AUC of NRS pain intensity scores 0-72 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
Measured: 0 to 72 hours post-surgery
AUC of NRS pain intensity scores 0-96 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
Measured: 0 to 96 hours post-surgery
AUC of NRS pain intensity scores 0-120 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
Measured: 0 to 120 hours post-surgery
Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 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.
Measured: 0 to 72 hours post-surgery
Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 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.
Measured: 0 to 96 hours post-surgery
Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 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.
Measured: 0 to 120 hours post-surgery
Percentage of opioid-free subjects through 72 hours post-surgery
Proportion of subjects who consumed no opioid medication from the end of surgery through 72 hours.
Measured: 0 to 72 hours post-surgery
Percentage of opioid-free subjects through 96 hours post-surgery
Proportion of subjects who consumed no opioid medication from the end of surgery through 96 hours.
Measured: 0 to 96 hours post-surgery
Percentage of opioid-free subjects through 120 hours post-surgery
Proportion of subjects who consumed no opioid medication from the end of surgery through 120 hours.
Measured: 0 to 120 hours post-surgery
Median time to first postsurgical opioid consumption
Time from end of surgery to administration of the first postsurgical opioid dose.
Measured: End of surgery through 168 hours post-surgery
Plasma bupivacaine maximum observed concentration (Cmax)
Maximum observed plasma bupivacaine concentration following single-dose administration
Measured: Pre-dose through 168 hours post-block administration
Time to maximum plasma bupivacaine concentration (Tmax)
Time from end of block administration to the maximum observed plasma bupivacaine concentration.
Measured: Pre-dose through 168 hours post-block administration
Apparent terminal elimination half-life of bupivacaine (t½el)
Apparent terminal elimination half-life of plasma bupivacaine
Measured: Pre-dose through 168 hours post-block administration
Apparent clearance of bupivacaine (CL/F)
Apparent clearance of bupivacaine following perineural administration, derived by non-compartmental analysis.
Measured: Pre-dose through 168 hours post-block administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start10 Mar 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rebel Medicine Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jayant Agarwal, MD, Study director, Rebel Medicine Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574385
- Sponsor's protocol ID
- RBL-201
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07574385
- Acronym / sponsor ID
- RBL-201
- Conditions
- Hallux Valgus, Bunionectomy
- Keywords
- ALX006, Bupivacaine, Popliteal fossa nerve block, Analgesia, Post-operative analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rebel Medicine IncIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 7 May 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALX006 100 mg | Experimental | Drug: ALX006 (bupivacaine extended-release injection), Procedure: Sciatic Nerve BlockSingle-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. |
| ALX006 150 mg | Experimental | Drug: ALX006 (bupivacaine extended-release injection), Procedure: Sciatic Nerve BlockSingle-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. |
| ALX006 200 mg | Experimental | Drug: ALX006 (bupivacaine extended-release injection), Procedure: Sciatic Nerve BlockSingle-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. |
| MARCAINE 0.25% | Active comparator | Drug: Bupivacaine Hcl 0.25% Inj, Procedure: Sciatic Nerve BlockSingle-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
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 |
|---|---|---|
| ALX006 (bupivacaine extended-release injection)ALX006 (50 mg/mL bupivacaine free base) | Drug | ALX006 100 mg, ALX006 150 mg, ALX006 200 mg |
| Bupivacaine Hcl 0.25% InjAlso: MARCAINE 0.25%Bupivacaine HCl 0.25% plain (2.5 mg/mL) | Drug | MARCAINE 0.25% |
| Sciatic Nerve BlockAlso: Sciatic Nerve Block in the Popliteal FossaSciatic nerve block in the popliteal fossa | Procedure or surgery | ALX006 100 mg, ALX006 150 mg, ALX006 200 mg, MARCAINE 0.25% |
Primary outcome
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
14 secondary outcomes
AUC of NRS pain intensity scores 0-72 hours post-surgery
Time frame: 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
AUC of NRS pain intensity scores 0-120 hours post-surgery
Time frame: 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
Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 0 to 96 hours post-surgery
Time frame: 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
Percentage of opioid-free subjects through 72 hours post-surgery
Time frame: 0 to 72 hours post-surgery
Percentage of opioid-free subjects through 96 hours post-surgery
Time frame: 0 to 96 hours post-surgery
Percentage of opioid-free subjects through 120 hours post-surgery
Time frame: 0 to 120 hours post-surgery
Median time to first postsurgical opioid consumption
Time frame: End of surgery through 168 hours post-surgery
Plasma bupivacaine maximum observed concentration (Cmax)
Time frame: 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
Apparent terminal elimination half-life of bupivacaine (t½el)
Time frame: Pre-dose through 168 hours post-block administration
Apparent clearance of bupivacaine (CL/F)
Time frame: Pre-dose through 168 hours post-block administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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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.
Jayant Agarwal, MD study director
Rebel Medicine Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALX006 (bupivacaine extended-release injection), Bupivacaine Hcl 0.25% Inj and Sciatic Nerve Block in people with Hallux Valgus and Bunionectomy, run by Rebel Medicine Inc at 1 site in United States.
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 6 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caleb Lade, MD (918-808-8399, caleb.lade@rebelmedicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: From start of nerve block procedure through 360 Hour Visit (Day 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.