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?

Local anesthetic infiltration is a primary source of acute pain during stereotactic procedures.

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?

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

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+