Total Knee Replacement SurgeryPhase 3STRIDE-PAINNCT07548385
Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN
A Phase 3 study testing Suzetrigine in people with Total Knee Replacement Surgery and Post-operative Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control. 1. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Knee Replacement Surgery, Post-operative Pain
- What is being tested?
- Suzetrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to 23 Feb 2027
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Adults 18-85 years old
- Scheduled to undergo total knee replacement surgery
- All genders
Who cannot join
- Any individual who meets any of the following criteria will be excluded from participation in this study:
- American Society of Anesthesiology Physical Classification (ASA) Class V
- Urgent or emergent surgery
- Contraindications to administration of Suzetrigine:
- Patients who take moderate-to-severe CYP3A inhibitors (such as Ritonavir, Voriconazole, and Clarithromycin)
- Patients who take moderate-to-severe CYP3A inducers (such as Phenytoin, Carbamazapine, and Rifabutin)
Show all 11Show fewer
- Patients with moderate to severe hepatic impairment
- History of substance use disorder or chronic opioid use or alcohol abuse
- Reoperation
- Patient refusal or inability to consent
- Pregnancy
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
Mount Sinai West
New York, New York, 10019
Michael Lazar, MD, 212-523-2500, michael.lazar@mountsinai.org
Himani Bhatt, DO, 212-523-2500, himani.bhatt@mountsinai.org
About this study
This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control.
- Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery?
- Dose Suzetrigine given pre-operatively decrease the visual analog pain scale pain scores after total knee replacement surgery? Study participants will be randomly assigned to receive either Suzetrigine medication or placebo medication.
- Being tested
- Suzetrigine, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
Suzetrigine is a new pain medication that works by inhibiting sodium channels (NAV 1.8) on pain nerves in the peripheral nervous system. By inhibiting this sodium channel on peripheral nerves it blocks pain signals from reaching the spinal cord and brain, decreasing pain.
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Suzetrigine | Experimental | Participants will receive 100 mg loading dose (2 pills) of Suzetrigine medication pre-operatively, then 50 mg dose (1 pill) of Suzetrigine every 12 hours for total of 5 days. Receives: Drug: Suzetrigine |
| Placebo | Placebo comparator | Participants will receive 2 pills that are made to look like the Suzetrigine pill to take per-operatively, then 1 pill every 12 hours for a total of 5 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Total amount of opioid consumption required post-operatively.
Measured: 5 days
Secondary outcomes (1)
Visual analog pain scale
Participants perceived post-operative pain measured daily using the visual analog scale for pain. Total score is 0 to 10, higher score indicates more pain.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study startApr 2026 (estimated)
- Primary completion23 Feb 2027 (estimated)
- Study completion23 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Replacement SurgeryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Lazar, Icahn School of Medicine at Mount Sinai
- Investigators
- Michael Lazar, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548385
- Sponsor's protocol ID
- STUDY-25-01392
- Acronym
- STRIDE-PAIN
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We are not sharing IPD to protect participant privacy, maintaining study integrity, and respecting intellectual property
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN
- ClinicalTrials.gov ID
- NCT07548385
- Acronym / sponsor ID
- STRIDE-PAIN / STUDY-25-01392
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 23 Feb 2027 (estimated)
- First posted
- 23 Apr 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 prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control.
- Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery?
- Dose Suzetrigine given pre-operatively decrease the visual analog pain scale pain scores after total knee replacement surgery? Study participants will be randomly assigned to receive either Suzetrigine medication or placebo medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suzetrigine | Experimental | Drug: SuzetrigineParticipants will receive 100 mg loading dose (2 pills) of Suzetrigine medication pre-operatively, then 50 mg dose (1 pill) of Suzetrigine every 12 hours for total of 5 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive 2 pills that are made to look like the Suzetrigine pill to take per-operatively, then 1 pill every 12 hours for a total of 5 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Adults 18-85 years old
- Scheduled to undergo total knee replacement surgery
- All genders
Key exclusion criteria (11 listed)
- Any individual who meets any of the following criteria will be excluded from participation in this study:
- American Society of Anesthesiology Physical Classification (ASA) Class V
- Urgent or emergent surgery
- Contraindications to administration of Suzetrigine:
- History of substance use disorder or chronic opioid use or alcohol abuse
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 |
|---|---|---|
| SuzetrigineSuzetrigine is a new pain medication that works by inhibiting sodium channels (NAV 1.8) on pain nerves in the peripheral nervous system. By inhibiting this sodium channel on peripheral nerves it blocks pain signals from reaching the spinal cord and brain, decreasing pain. | Drug | Suzetrigine |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Opioid Consumption
Time frame: 5 days
Total amount of opioid consumption required post-operatively.
1 secondary outcome
Visual analog pain scale
Time frame: 5 days
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 23 Apr 2026.
- Individual participant dataSharing planned: No. We are not sharing IPD to protect participant privacy, maintaining study integrity, and respecting intellectual property
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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.
Michael Lazar, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Suzetrigine in people with Total Knee Replacement Surgery and Post-operative Pain, run by Icahn School of Medicine at Mount Sinai 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 4 inclusion and 11 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 23 Apr 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Michael Lazar, MD (212-523-2500, michael.lazar@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption (time frame: 5 days). 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 23 Apr 2026.