Suzetrigine for Knee Arthritis

Not yet recruiting at 2 trial locations
DF
Overseen ByDarrell Favors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how well Suzetrigine aids in pain management for individuals undergoing knee replacement surgery due to arthritis. Participants will receive Suzetrigine as part of a pain relief plan alongside usual care. Ideal candidates for this trial are those scheduled for knee replacement surgery due to knee arthritis who do not have significant health issues like heart or liver problems and are not on certain medications. As a Phase 4 trial, Suzetrigine is already FDA-approved and proven effective, and this research seeks to understand its benefits for a broader range of patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking CYP3A inhibitors. It's best to discuss your specific medications with the trial team.

What is the safety track record for Suzetrigine?

Studies have shown that Suzetrigine is generally safe and well-tolerated by patients. Earlier research reported no serious unwanted effects related to the drug, which is encouraging for those considering joining a trial. Additionally, the FDA has approved Suzetrigine as a non-opioid pain medicine for treating moderate to severe sudden pain. This approval indicates strong confidence in its safety when used as directed. Although more information is needed about its long-term safety, current findings are promising for short-term use.12345

Why are researchers enthusiastic about this study treatment?

Suzetrigine is unique because it offers a potentially faster relief option for knee arthritis compared to traditional treatments like NSAIDs or corticosteroids. Unlike these standard treatments, which often require weeks to show results and primarily focus on reducing inflammation, Suzetrigine is administered orally in a short, 14-day course and promises rapid effects. Researchers are excited because it targets knee arthritis differently, with the potential for significant improvements in pain and mobility in just days, making it a promising alternative for those seeking quicker symptom relief.

What is the effectiveness track record for Suzetrigine in treating knee arthritis?

Research has shown that Suzetrigine, also known as Journavx, reduces moderate to severe sudden pain. Studies have found that Suzetrigine outperforms a placebo (a sugar pill) in lowering pain levels. In one study, 90.7% of patients rated its effectiveness as excellent when combined with other treatments. Additionally, Suzetrigine offers pain relief comparable to opioids but with fewer side effects. These findings suggest that Suzetrigine can be an effective option for managing pain after knee surgery.14678

Who Is on the Research Team?

AP

Ajay Premkumar, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults with knee arthritis who are scheduled to have total knee replacement surgery. Participants should be able to follow the study plan and receive standard pain management after surgery.

Inclusion Criteria

I am having my first knee replacement surgery for knee osteoarthritis.
I am between 18 and 95 years old.

Exclusion Criteria

Patients who are pregnant
I have used opioids daily within 4 weeks before my surgery.
I currently have an active peptic ulcer.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Suzetrigine as part of a multimodal analgesic regimen for up to 14 days post-surgery

2 weeks
Daily monitoring with diaries and sleep tracker

Follow-up

Participants are monitored for safety and effectiveness, including surveys and assessments at 3 months post-surgery

3 months
Surveys at 1 week, 2 weeks, and 3 months post-surgery

What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine

Trial Overview

The study tests Suzetrigine, given along with usual pain medications, to see if it helps reduce pain and the need for opioids after knee replacement surgery. All participants will get Suzetrigine as part of their care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Suzetrigine Regimen ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Vertex Pharmaceuticals Incorporated

Industry Sponsor

Trials
267
Recruited
36,100+
Dr. David Altshuler profile image

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani profile image

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology

Citations

Study Details | NCT07219888 | Comparison of Suzetrigine ...

The purpose this study is determine whether postoperative oral dosage of suzetrigine is effective at controlling postoperative pain and reducing analgesic ...

The effectiveness and value of suzetrigine for moderate ... - PMC

Suzetrigine demonstrated superior pain relief compared with placebo in both trials; the least squares mean difference (LSMD) in SPID48 between suzetrigine

FDA Approves Novel Non-Opioid Treatment for Moderate ...

Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo.

Evaluating Suzetrigine for Pain Control Following TKA

Phase 3 clinical trials have shown that suzetrigine provides pain relief comparable to opioids, effectively reducing pain scores, with fewer adverse effects.

How Was JOURNAVX® (suzetrigine) Studied?

Results With JOURNAVX From Clinical Studies. JOURNAVX effectively reduced moderate-to-severe acute pain after surgery a. a Compared to placebo (sugar pill).

Between promise and peril: role of suzetrigine as a non-opioid ...

Suzetrigine is a non-opioid analgesic that inhibits the voltage-gated sodium channel Na v 1.8 in peripheral sensory neurons with high selectivity.

Suzetrigine as a Non-Opioid Analgesic: Balancing Promise ...

Importantly, serious drug-related adverse events have not been reported to date, though long-term safety data are still limited. The recommended ...

Suzetrigine for Treatment and Reduction of Intense ...

Summary: This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, ...