Role of Suzetrigine as a Part of a Multimodal Regimen to Reduce Pain and Opioid Use After Total Knee Arthroplasty

NCT07624526 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2026P000242
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief 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 care.

Conditions

Knee Arthritis; Knee Osteoarthritis

Keywords

Total knee arthroplasty; Suzetrigine

Outcome Measures

Primary Outcomes (3)

• 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.

  Day 0-14 postoperative

• Average daily opioid consumption

  Postoperative opioid consumption will be quantified in morphine milligram equivalents (MME) during postoperative days 0-14.

  Day 0-14 postoperative

• Cumulative opioid consumption

  Postoperative opioid consumption will be quantified as cumulative MME at 3 weeks and 3 months.

  3 weeks and 3 months postoperative

Secondary Outcomes (7)

• Nausea scores postoperative

  Day 0-14 post-operative

• Total sleep time

  Day 0-14 post-operative

• Sleep efficiency

  Day 0-14 post-operative

• Sleep latency

  Day 0-14 post-operative

• Wake after sleep onset (WASO)

  Day 0-14 post-operative

Study Arms (1)

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.

Drug: Suzetrigine

Interventions

Suzetrigine DRUG

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.

Also known as: JOURNAVX®

Suzetrigine Regimen Arm

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
• Patients between the ages of 18 and 95 years.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Emory University: lead
• Vertex Pharmaceuticals Incorporated: collaborator

Study Sites (3)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory Clinic at Executive Park

Atlanta, Georgia, 30329, United States

Location

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ajay Premkumar, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darrell Favors

CONTACT

404-313-3276; darrell.favors@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)