80 Participants NeededMy employer runs this trial

Suzetrigine for Pain Relief

WJ
Overseen ByWendy Jenkins, BSN RN, CCRC
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 a new pain relief treatment called suzetrigine to reduce pain from local anesthetic during certain head procedures. Researchers aim to determine if suzetrigine is more effective than acetaminophen, which is also under evaluation. Individuals scheduled for a procedure requiring a special head frame may qualify for this trial. Participants will take the treatment at home before their procedure to assess its effectiveness in managing pain. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the development of a potential new standard in pain management.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found Suzetrigine to be generally safe and well-tolerated, causing fewer common side effects like nausea and dizziness compared to other painkillers. Another study demonstrated that Suzetrigine had fewer negative effects than both a placebo and acetaminophen with hydrocodone, a strong painkiller. Importantly, the FDA has approved Suzetrigine for use in moderate to severe sudden pain, and it has shown similar pain relief to opioids but with fewer side effects like vomiting. Overall, research suggests that Suzetrigine is a safe option for treating sudden pain.12345

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

Suzetrigine is unique because, unlike traditional pain relief options like acetaminophen, it is an experimental treatment that may offer a new mechanism of action. Researchers are excited because Suzetrigine could target pain pathways more directly or effectively, potentially providing faster or longer-lasting relief. While most pain relievers work by blocking pain signals or reducing inflammation, Suzetrigine might offer a novel approach that could benefit patients who don’t respond well to current options.

What evidence suggests that this trial's treatments could be effective for pain relief?

Research has shown that suzetrigine, which participants in this trial may receive, effectively reduces moderate-to-severe sudden pain. Studies indicate it provides pain relief similar to oral opioids but with fewer side effects, such as nausea. In clinical trials, 83.2% of patients rated their pain relief from suzetrigine as "good" to "excellent." This medication blocks a specific pain pathway in the body, making it a promising non-opioid option for managing pain. Overall, suzetrigine has significantly reduced pain and may help those seeking effective relief without the risks associated with opioids. Another treatment option in this trial is acetaminophen, serving as an active comparator.46789

Who Is on the Research Team?

SB

Stephen B Tatter, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for people who are about to have a medical procedure that requires a stereotactic head frame. Only those scheduled for this specific type of procedure can join.

Inclusion Criteria

I am scheduled for a procedure that needs a stereotactic head frame.

Exclusion Criteria

I am scheduled for a procedure that needs a stereotactic head frame.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants self-administer either Suzetrigine or Acetaminophen at home prior to the procedure to assess pain reduction during local anesthetic infiltration and head frame application

Single day
1 visit (in-person)

Follow-up

Participants are monitored for pain and anxiety levels using VAS scores immediately after the procedure and reassessed at Hour 24

24 hours
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine

Trial Overview

The study compares two pain relief options—Suzetrigine and acetaminophen—for managing pain caused by local anesthetic during the placement of a stereotactic head frame.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: SuzetrigineExperimental Treatment1 Intervention
Group II: AcetaminophenActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40117446/

Suzetrigine, a Nonopioid Na V 1.8 Inhibitor for Treatment of ...

Conclusions: As compared with placebo, suzetrigine reduced moderate-to-severe acute pain over 48 h after abdominoplasty or bunionectomy. Pain ...

The effectiveness and value of suzetrigine for moderate ...

Fewer than half of patients report adequate pain relief, which can impair daily function and increase the risk of chronic pain. Currently, ...

Suzetrigine for Acute Pain:Effectiveness and Value

We aimed to assess the clinical effectiveness and safety of suzetrigine as an add-on to non-systemic treatments for patients with moderate to ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41481839/

Suzetrigine, a selective NaV1.8 inhibitor in acute and ...

Suzetrigine represents a promising nonopioid alternative for acute pain and has the potential to fill a significant gap in pain management.

Suzetrigine: A novel nonopioid systemic analgesic

Suzetrigine has certainly shown it is an effective analgesic for acute pain and may have an important role as another option for multimodal ...

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

The drug displayed a favorable safety profile with a lower incidence of common opioid-related adverse effects, such as nausea and dizziness, and ...

Suzetrigine: A Novel, Peripherally Acting Analgesic

Suzetrigine was generally safe and well tolerated with a lower incidence of adverse events than placebo and the acetaminophen/hydrocodone ...

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

The FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic to treat moderate to severe acute ...

Suzetrigine for Acute Pain Control in Patients With Multiple ...

Suzetrigine has also been shown to have comparable analgesia to oral opioids with fewer side effects, such as nausea, vomiting, and need for rescue pain ...