235 Participants NeededMy employer runs this trial

Suzetrigine for Postoperative Pain

(STRIDE-PAIN Trial)

ML
HB
Overseen ByHimani Bhatt, DO
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Icahn School of Medicine at Mount Sinai
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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 tests Suzetrigine, a new pain medication, to determine its effectiveness in reducing pain and the need for opioids after knee replacement surgery. Participants will receive either Suzetrigine or a placebo before surgery. The trial seeks to discover if Suzetrigine can lessen pain and decrease opioid use post-surgery. Individuals planning a total knee replacement, without certain medical conditions or medication interactions, may qualify for this trial. As a Phase 3 trial, this research represents the final step before FDA approval, giving participants the opportunity to contribute to the potential availability of a new pain management option.

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

You may need to stop taking certain medications if they are moderate-to-severe CYP3A inhibitors or inducers, like Ritonavir or Phenytoin. The trial does not specify other medication restrictions.

Is there any evidence suggesting that Suzetrigine is likely to be safe for humans?

Studies have shown that Suzetrigine is generally safe and well-tolerated. Research indicates it causes fewer side effects than a sugar pill (placebo) or the pain medication acetaminophen/hydrocodone. Common side effects, such as nausea and vomiting, occur less frequently with Suzetrigine. Most patients report good to excellent pain relief. Additionally, the FDA has approved Suzetrigine for pain control based on strong safety and effectiveness data from previous studies.12345

Why do researchers think this study treatment might be promising for postoperative pain?

Most treatments for postoperative pain involve opioids or nonsteroidal anti-inflammatory drugs (NSAIDs). Suzetrigine is unique because it offers a new approach by targeting specific pain pathways without relying on these common pain relievers. This drug has an innovative mechanism of action that could potentially reduce pain more effectively while minimizing the risk of addiction associated with opioids. Researchers are excited about Suzetrigine because it might offer a safer, non-opioid alternative for managing postoperative pain, addressing a significant need in pain management.

What evidence suggests that Suzetrigine might be an effective treatment for postoperative pain?

Research has shown that Suzetrigine, a new pain medication, holds promise for reducing post-surgical pain. In this trial, participants will receive either Suzetrigine or a placebo. Specifically, earlier studies demonstrated that Suzetrigine significantly reduced pain compared to a placebo and helped nearly 91% of patients avoid opioids after surgery. The medication blocks certain pain signals, leading to effective pain relief. While some studies report modest pain relief, others highlight its potential for providing good to excellent pain control without opioids.24678

Who Is on the Research Team?

ML

Michael Lazar, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 85 of any gender who are scheduled to have total knee replacement surgery. People outside this age range or not having this surgery cannot participate.

Inclusion Criteria

I am between 18 and 85 years old.
My gender does not affect my eligibility.
I am scheduled to have total knee replacement surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Suzetrigine or placebo pre-operatively and continue with doses every 12 hours for 5 days

5 days
Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine

Trial Overview

The study tests whether adding Suzetrigine, a new pain medication given before surgery, helps reduce pain and the need for opioids after knee replacement compared to a placebo. Participants are randomly assigned to receive either Suzetrigine or a placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: SuzetrigineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41790692/

Suzetrigine (a NaV1.8 inhibitor) versus placebo for acute ...

Conclusion: Suzetrigine produced modest reductions in pain at 24 to 48 hours versus placebo. Because opioid consumption was not consistently ...

Pain Suzetrigine Data Reveal Reduced Postoperative ...

SALT LAKE CITY—New data show that suzetrigine (Journavx, Vertex) results in opioid-free recovery for 90.9% of patients treated with the ...

Association of Suzetrigine With Postoperative Outcomes ...

A novel non-opioid analgesic, Suzetrigine, may be able to effectively manage postoperative pain without some of the psychological and economic ...

Data Support Suzetrigine's Use for Acute Pain Following ...

Phase 4 data show suzetrigine controls post–plastic surgery pain, keeping nearly 91% of patients opioid free with good pain ratings and ...

The effectiveness and value of suzetrigine for moderate ...

Patients receiving suzetrigine after bunionectomy showed delayed pain relief (longer time to a drop of ≥2 points on the NPRS) than observed in ...

Clinical Efficacy and Safety Profile of Suzetrigine: A Novel Non ...

These randomized, double-blind studies assessed the analgesic efficacy of suzetrigine in postoperative pain management following bunionectomy ...

Efficacy and Safety of Suzetrigine for Acute Postoperative ...

This systematic review and meta-analysis aimed to assess the efficacy and safety of suzetrigine compared to placebo in adults with acute postoperative pain. A ...

Safety and efficacy of Suzetrigine (VX-548) for acute ...

Suzetrigine shows strong efficacy and a favorable safety profile in acute post-surgical and neuropathic pain. •. Suzetrigine significantly reduces the risk of ...