Knee ArthritisPhase 4NCT07624526
Role of Suzetrigine as a Part of a Multimodal Regimen to Reduce Pain and Opioid Use After Total Knee Arthroplasty
A Phase 4 study testing Suzetrigine in people with Knee Arthritis and Knee Osteoarthritis, run by Emory University at 3 sites in United States.
Trial summary
This study is a prospective, single-arm interventional trial enrolling patients undergoing total knee arthroplasty (TKA) for knee arthritis. All participants will receive Suzetrigine (brand name Journavx by Vertex Pharma) as part of a standardized multimodal perioperative analgesic regimen in addition to standard of… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Knee Arthritis, Knee Osteoarthritis
- What is being tested?
- Suzetrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2026to Aug 2028
- Phase
- Phase 4
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
- Patients between the ages of 18 and 95 years.
Who cannot join
- Patients with concurrent and significant injuries to other bones or organs.
- Patients with local infections.
- Minors unable to provide informed consent for participation in the study.
- Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
- Patients with pre-existing immune suppression, where further immune suppression with GCs could warrant unwarranted or unneeded risk.
- Patients with preoperative opioid use, defined as daily use less than 4 weeks before the index surgery.
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- Patients with a history of severe heart disease (NYHA2), renal failure, or liver dysfunction
- Patients with active peptic ulcer disease.
- Patients neurological or psychiatric diseases, potentially influencing pain perception
- Patients who are pregnant.
- Patients with a history of alcohol or medical abuse, allergies to glucocorticoids, current daily use of glucocorticoids.
- Patients who are unable to take NSAIDs.
- Patients who receive Deep Venous Thrombosis (DVT) prophylaxis different than Aspirin (81mg) twice daily (BID).
- Patients who have known diabetes mellitus as defined with an A1C greater than 6.5%.
- Patients currently taking CYP3A inhibitors
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Emory Clinic
Atlanta, Georgia, 30322
Emory Clinic at Executive Park
Atlanta, Georgia, 30329
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329
About this study
This study is a prospective, single-arm interventional trial enrolling patients undergoing total knee arthroplasty (TKA) for knee arthritis. All participants will receive Suzetrigine (brand name Journavx by Vertex Pharma) as part of a standardized multimodal perioperative analgesic regimen in addition to standard of care.
Read the detailed description
The objective of the study is to determine the effect suzetrigine has on postoperative pain, opioid use, sleep quality, and patient satisfaction when it is used as part of a multimodal pain regimen prescribed to patients after total knee arthroplasty.
The study will enroll eligible participants who are scheduled to receive a total knee arthroplasty. Participants will first consent to participate in the research study. They will then be asked to complete certain baseline measurements and instructed to begin wearing a device on their wrist that will quantify their activity and sleep quality ("sleep tracker"). They will complete a baseline KOOS JR survey. There are no additional surveys or diaries to complete pre-operatively. They will receive a suzetrigine prescription (the intervention) on the day of their total knee arthroplasty after the procedure has been completed in addition to the standard of care pain control regimen after surgery. They will complete a diary for a set time after surgery, and subject will continue to wear the sleep tracker for up to 2 weeks post-surgery. They will complete a daily sleep diary for 14 days after surgery to document sleep duration, sleep quality, nighttime awakenings, and other related factors. They will also complete a diary for 14 days after surgery that asks them to report their pain level 3 times daily, their nausea level 3 times daily, and the number of narcotic pills taken daily, and continue to wear their activity and sleep tracker. They will be asked to complete a pill tracking chart to confirm they are taking Journavx as directed for 14 days after surgery. 1 week and 2 weeks after surgery, they will complete a survey that quantifies their sleep related impairment. Approximately 3 months after surgery, subjects will complete another survey. Participants will have interactions with the study team until approximately 3 months after surgery.
- Conditions
- Knee Arthritis, Knee Osteoarthritis
- Being tested
- Suzetrigine
- Keywords
- Total knee arthroplasty, Suzetrigine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
Also called JOURNAVX®
Suzetrigine is an orally administered, selective NaV1.8 voltage-gated sodium channel inhibitor being investigated as a non-opioid analgesic for the treatment of pain through inhibition of pain signal transmission in peripheral sensory neurons.
| Study group | Role | What they receive |
|---|---|---|
| Suzetrigine Regimen Arm | Experimental | Suzetrigine (JOURNAVX®) administered orally consisting of a course that lasts up to a maximum of 14 days.
The starting dose will be 100 mg orally taken as two 50 mg tablets on an empty stomach (at least 1 hour before or 2 hours after food). Maintenance dosing will begin 12 hours after the initial dose, at which point patients will take 50 mg orally every 12 hours. Receives: Drug: Suzetrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain intensity score on the Numeric Rating Scale (NRS)
Pain will be measured using a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, using a Visual Analog Pain Scale (VAS-pain). Higher score correlates with worse outcome.
Measured: Day 0-14 postoperative
Average daily opioid consumption
Postoperative opioid consumption will be quantified in morphine milligram equivalents (MME) during postoperative days 0-14.
Measured: Day 0-14 postoperative
Cumulative opioid consumption
Postoperative opioid consumption will be quantified as cumulative MME at 3 weeks and 3 months.
Measured: 3 weeks and 3 months postoperative
Secondary outcomes (7)
Nausea scores postoperative
A nausea assessment will be assessed using the Visual Analog Nausea Scale (VAS-nausea), which is ranked from 0 (no nausea) to 10 (highest amount of nausea). Patients will be asked to fill out the VAS-nausea each day until post-operative day 14.
Measured: Day 0-14 post-operative
Total sleep time
Total sleep time will be collected using actigraphy during postoperative days 0-14.
Measured: Day 0-14 post-operative
Sleep efficiency
Sleep efficiency will be measured by recording the ratio of time asleep to time in bed, using actigraphy during postoperative days 0-14.
Measured: Day 0-14 post-operative
Sleep latency
Sleep latency will be measured by recording the time from "lights out" to sleep onset, using actigraphy during postoperative days 0-14.
Measured: Day 0-14 post-operative
Wake after sleep onset (WASO)
Wake after sleep onset (WASO) will be assessed using actigraphy during postoperative days 0-14.
Measured: Day 0-14 post-operative
EQ5D Score
Health-related quality of life measure using the EQ-5D questionnaire, which assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a summary index score, where 1 represents full health and 0 represents death (higher values indicating better health status).
Measured: 3 months post-operative
KOOS Jr Score
Patient-reported knee function assessed using the Knee Injury and Osteoarthritis Outcome Score Junior (KOOS Jr). The KOOS Jr is a validated short-form instrument derived from the full KOOS, designed to evaluate knee health based on key items related to pain, symptoms, and physical function. Scores are transformed to a 0 to 100 scale, with higher scores indicating better knee function and fewer symptoms.
Measured: Baseline, 3 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Responsible party
- Principal investigator, Ajay Premkumar, Emory University
- Investigators
- Ajay Premkumar, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624526
- Sponsor's protocol ID
- 2026P000242
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Suzetrigine as a Part of a Multimodal Regimen to Reduce Pain and Opioid Use After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07624526
- Acronym / sponsor ID
- 2026P000242
- Conditions
- Knee Arthritis, Knee Osteoarthritis
- Keywords
- Total knee arthroplasty, Suzetrigine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Study start
- Jul 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 3 Jun 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 study is a prospective, single-arm interventional trial enrolling patients undergoing total knee arthroplasty (TKA) for knee arthritis. All participants will receive Suzetrigine (brand name Journavx by Vertex Pharma) as part of a standardized multimodal perioperative analgesic regimen in addition to standard of care.
Detailed description
The objective of the study is to determine the effect suzetrigine has on postoperative pain, opioid use, sleep quality, and patient satisfaction when it is used as part of a multimodal pain regimen prescribed to patients after total knee arthroplasty.
The study will enroll eligible participants who are scheduled to receive a total knee arthroplasty. Participants will first consent to participate in the research study. They will then be asked to complete certain baseline measurements and instructed to begin wearing a device on their wrist that will quantify their activity and sleep quality ("sleep tracker"). They will complete a baseline KOOS JR survey. There are no additional surveys or diaries to complete pre-operatively. They will receive a suzetrigine prescription (the intervention) on the day of their total knee arthroplasty after the procedure has been completed in addition to the standard of care pain control regimen after surgery. They will complete a diary for a set time after surgery, and subject will continue to wear the sleep tracker for up to 2 weeks post-surgery. They will complete a daily sleep diary for 14 days after surgery to document sleep duration, sleep quality, nighttime awakenings, and other related factors. They will also complete a diary for 14 days after surgery that asks them to report their pain level 3 times daily, their nausea level 3 times daily, and the number of narcotic pills taken daily, and continue to wear their activity and sleep tracker. They will be asked to complete a pill tracking chart to confirm they are taking Journavx as directed for 14 days after surgery. 1 week and 2 weeks after surgery, they will complete a survey that quantifies their sleep related impairment. Approximately 3 months after surgery, subjects will complete another survey. Participants will have interactions with the study team until approximately 3 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suzetrigine Regimen Arm | Experimental | Drug: SuzetrigineSuzetrigine (JOURNAVX®) administered orally consisting of a course that lasts up to a maximum of 14 days. The starting dose will be 100 mg orally taken as two 50 mg tablets on an empty stomach (at least 1 hour before or 2 hours after food). Maintenance dosing will begin 12 hours after the initial dose, at which point patients will take 50 mg orally every 12 hours. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
- Patients between the ages of 18 and 95 years.
Key exclusion criteria (15 listed)
- Patients with concurrent and significant injuries to other bones or organs.
- Patients with local infections.
- Minors unable to provide informed consent for participation in the study.
- Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
- Patients with pre-existing immune suppression, where further immune suppression with GCs could warrant unwarranted or unneeded risk.
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 |
|---|---|---|
| SuzetrigineAlso: JOURNAVX®Suzetrigine is an orally administered, selective NaV1.8 voltage-gated sodium channel inhibitor being investigated as a non-opioid analgesic for the treatment of pain through inhibition of pain signal transmission in peripheral sensory neurons. | Drug | Suzetrigine Regimen Arm |
Primary outcome
Mean pain intensity score on the Numeric Rating Scale (NRS)
Time frame: Day 0-14 postoperative
Pain will be measured using a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, using a Visual Analog Pain Scale (VAS-pain). Higher score correlates with worse outcome.
Average daily opioid consumption
Time frame: Day 0-14 postoperative
Postoperative opioid consumption will be quantified in morphine milligram equivalents (MME) during postoperative days 0-14.
Cumulative opioid consumption
Time frame: 3 weeks and 3 months postoperative
Postoperative opioid consumption will be quantified as cumulative MME at 3 weeks and 3 months.
7 secondary outcomes
Nausea scores postoperative
Time frame: Day 0-14 post-operative
Total sleep time
Time frame: Day 0-14 post-operative
Sleep efficiency
Time frame: Day 0-14 post-operative
Sleep latency
Time frame: Day 0-14 post-operative
Wake after sleep onset (WASO)
Time frame: Day 0-14 post-operative
EQ5D Score
Time frame: 3 months post-operative
KOOS Jr Score
Time frame: Baseline, 3 months post-operative
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 3 Jun 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.
Ajay Premkumar, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suzetrigine in people with Knee Arthritis and Knee Osteoarthritis, run by Emory University at 3 sites 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 2 inclusion and 15 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: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Darrell Favors (404-313-3276, darrell.favors@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pain intensity score on the Numeric Rating Scale (NRS) (time frame: Day 0-14 postoperative). The study lists 3 primary outcomes in all. 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 3 Jun 2026.