A Phase 4 interventional study of Suzetrigine in Ankle Osteoarthritis, Postoperative Pain and Acute Pain, sponsored by Soheil Ashkani Esfahani. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Soheil Ashkani Esfahani · Phase 4, Interventional, and Treatment
Among 18 studies testing suzetrigine in Pain, Postoperative — 17 open to participants now, 17 under way, 4 of them phase 3. suzetrigine · Pain, Postoperative.
Among the 18 studies testing suzetrigine in Pain, Postoperative, this one is the 18th largest by planned enrollment, is one of 15 that started in 2026, is one of 14 in phase 4, reaches primary completion later than 9 of the 16 other live ones, and was the 10th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 28 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →17 of the 18 studies testing suzetrigine in Pain, Postoperative are open now, in 1 country. Each count lists the studies.
suzetrigine: first FDA approval 2025 (JOURNAVX). What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →18 studies; the count open now beside each. This study's row is marked.
First in 2025; this study’s year is marked. 15 started in 2026.
Median enrollment 115 across the 18 interventional studies. Of the 1 that completed or were terminated, 0 (0%) have results posted.
None of the 18 has an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Soheil Ashkani Esfahani as lead sponsor.
Soheil Ashkani Esfahani has 1 study filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
9 of the studies testing suzetrigine in Pain, Postoperative that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07539623Phase 3Icahn School of Medicine at Mount SinaiSuzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery | 2026-12-22 |
| NCT07548385Phase 3Icahn School of Medicine at Mount SinaiSuzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN | 2027-02-23 |
| NCT07839715Phase 3Vanderbilt University Medical CenterSuzetrigine Post DIEP | 2027-08 |
| NCT07355166University of California, Los AngelesSuzetrigine Versus Usual-care Opioids for Postop Pain in Sports | 2027-01 |
| NCT07821931Stanford UniversitySuzetrigine in Tonsillectomy for Opioid-sparing Pain Management | 2027-06 |
Among the 18 studies testing suzetrigine in Pain, Postoperative, from their registry updates:
This study is testing whether adding a non-opioid pain medicine called suzetrigine (Journavx) to the usual combination of pain medicines helps people recover more comfortably after ankle replacement surgery.
Adults aged 18 to 75 who are scheduled for a first-time total ankle replacement may join. Everyone who joins will receive suzetrigine in addition to their usual pain medicines. Study visits happen at the same times as normal follow-up appointments after surgery.
At these visits, participants will rate their pain, answer questionnaires about how pain affects daily life, mood, and physical activity, report how much pain medicine they have taken, report any side effects, and have their ankle motion measured.
Total ankle arthroplasty (TAA) causes substantial acute postoperative pain, typically managed with multimodal analgesia including acetaminophen, NSAIDs, and as-needed opioids. Reducing early postoperative opioid exposure is a recognized priority.
Suzetrigine is a selective NaV1.8 sodium channel inhibitor acting on peripheral pain-sensing neurons. This single-arm, open-label prospective cohort study enrolls patients undergoing primary TAA who will receive suzetrigine in addition to standard multimodal analgesia. Outcomes are compared with a historical control group of patients who underwent primary TAA at the same institution during the preceding five years and received standard multimodal analgesia alone, identified retrospectively.
The criteria were revised on the registry on Sep 30, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergoing primary total ankle arthroplasty receive oral suzetrigine in addition to the institution's standard multimodal analgesic regimen.
Drug: Suzetrigine
Oral suzetrigine administered postoperatively in addition to standard multimodal analgesia.
Also known as: Journavx
Cumulative Postoperative Opioid Consumption Through Postoperative Day 14
Cumulative opioid consumption will be calculated as the total amount of opioid medication used from postoperative day 0 through postoperative day 14 and converted to morphine milligram equivalents (MME). Higher MME values indicate greater opioid consumption.
Time frame: Postoperative day (POD) 0 through Postoperative Day 14
Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS)
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher NPRS scores indicate greater pain intensity.
Time frame: 24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery
Pain Interference Assessed by PROMIS Pain Interference 6b
Pain interference will be assessed using the Patient-Reported Outcomes Measurement Information System Short Form v1.0 - Pain Interference 6b (PROMIS Pain Interference 6b). The instrument contains 6 items assessing the extent to which pain interferes with activities and aspects of daily life. Raw scores range from 6 to 30 and are converted to standardized T-scores ranging from 41.0 to 78.3. Higher scores indicate greater pain interference and a worse outcome.
Time frame: 24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery
Pain Intensity Assessed by PROMIS Pain Intensity 3a
Pain intensity will be assessed using the Patient-Reported Outcomes Measurement Information System Scale v1.0 - Pain Intensity 3a (PROMIS Pain Intensity 3a). The instrument contains 3 items assessing worst pain, average pain, and current pain. Raw scores range from 3 to 15 and are converted to standardized T-scores ranging from 36.3 to 81.8. Higher scores indicate greater pain intensity and a worse outcome.
Time frame: 24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery
Physical Function Assessed by PROMIS Physical Function 10a
Physical function will be assessed using the Patient-Reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 10a (PROMIS Physical Function 10a). The instrument contains 10 items assessing the ability to perform physical activities and activities of daily living. Raw scores range from 10 to 50 and are converted to standardized T-scores ranging from 13.5 to 61.9. Higher scores indicate better physical function and a better outcome.
Time frame: 24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery
Pain Intensity Assessed by the Visual Analog Scale
Pain intensity will be assessed using the Visual Analog Scale (VAS). Possible scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity and a worse outcome.
Time frame: 24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery
Patient Satisfaction With Postoperative Pain Management
Patient satisfaction with postoperative pain management will be assessed using a 6-point Likert scale. Possible scores range from 0 to 5, with higher scores indicating greater satisfaction and a better outcome. Participants will also be asked an open-ended question regarding their experience with suzetrigine; the open-ended response is qualitative and is not included in the numerical satisfaction score.
Time frame: 24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery
Number of Participants With Adverse Events
The number and proportion of participants experiencing one or more adverse events will be recorded. Patient-reported adverse events will be collected using selected items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and clinician-reported adverse events will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: 2 weeks, 1 month, 3 months, 6 months after surgery
Severity of Adverse Events
Severity of clinician-reported adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), and patient-reported symptomatic adverse events will be assessed using selected items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Higher grades or response levels indicate greater adverse-event severity and a worse outcome. PRO-CTCAE consists of individual symptom items and does not produce a single overall composite score.
Time frame: 2 weeks, 1 month, 3 months, 6 months after surgery
Proportion of Participants Opioid-Free by Postoperative Day 14
The proportion of participants who are opioid-free by postoperative day 14 will be determined from recorded postoperative opioid use. Results will be reported as the percentage of participants who are opioid-free at postoperative day 14.
Time frame: Postoperative day 14
Proportion of Participants Requiring Rescue Analgesia
The proportion of participants requiring at least one rescue analgesic because of inadequate pain control will be recorded. Rescue analgesics include medications administered as needed when routine postoperative pain management is insufficient. A higher proportion indicates greater need for additional analgesia.
Time frame: Postoperative day 0 through postoperative day 14
Baseline Risk for Opioid Use Disorder Assessed by the Opioid Risk Tool for Opioid Use Disorder
Baseline risk for opioid use disorder will be assessed using the Opioid Risk Tool for Opioid Use Disorder (ORT-OUD), a 9-item self-report screening instrument. Total scores range from a minimum of 0 to a maximum of 9. Scores of 0-2 indicate lower risk and scores of 3-9 indicate higher risk for future opioid use disorder. Higher scores indicate greater risk and therefore a worse outcome.
Time frame: Preoperative baseline
Opioid Misuse Behaviors Assessed by the Current Opioid Misuse Measure
Postoperative opioid misuse behaviors will be assessed using the Current Opioid Misuse Measure (COMM), a 17-item self-report instrument. Each item is scored from 0 to 4, producing a total score ranging from a minimum of 0 to a maximum of 68. Higher scores indicate greater evidence of current opioid misuse behaviors and a worse outcome.
Time frame: Routine postoperative follow-up visits through 6 months after surgery at 2 weeks, 1 month, 3 months, 6 months
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared outside Mass General Brigham because the approved protocol limits data access to IRB-approved study staff and does not authorize external sharing.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's planned 12 months is below that.
Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Suzetrigine