Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen

NCT07525219 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: IRB00146434
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Analgesic Efficacy

Keywords

procedural prophylaxis; anesthetic infiltration; stereotactic head frame

Outcome Measures

Primary Outcomes (5)

• Visual Analog Scale (VAS-Anxiety) score

  A single consolidated VAS score (0-10) representing the pain experienced during the administration of local anesthetic across all four pin sites. This VAS is administered immediately after the local anesthetic injections are completed. For anxiety-VAS cutoff value = 40: the VAS score is ≥40 in 81% of patients with anxiety (sensitivity); the VAS score is \<40 in 70% of patients without anxiety (specificity); 67% of patients with a VAS score ≥ 40 have anxiety (PPV); 82% of patients with a VAS score \<40 do not have anxiety (NPV).

  Baseline

• Visual Analog Scale (VAS-Infiltration) score

  A single consolidated VAS score (0-10) representing the pain experienced during the administration of local anesthetic across all four pin sites. This VAS is administered immediately after the local anesthetic injections are completed. For anxiety-VAS cutoff value = 40: the VAS score is ≥40 in 81% of patients with anxiety (sensitivity); the VAS score is \<40 in 70% of patients without anxiety (specificity); 67% of patients with a VAS score ≥ 40 have anxiety (PPV); 82% of patients with a VAS score \<40 do not have anxiety (NPV).

  Baseline

• Visual Analog Scale (VAS-Pin Tightening) score

  A single consolidated VAS score (0-10) representing the pain experienced during the administration of local anesthetic across all four pin sites. This VAS is administered immediately after the local anesthetic injections are completed. For anxiety-VAS cutoff value = 40: the VAS score is ≥40 in 81% of patients with anxiety (sensitivity); the VAS score is \<40 in 70% of patients without anxiety (specificity); 67% of patients with a VAS score ≥ 40 have anxiety (PPV); 82% of patients with a VAS score \<40 do not have anxiety (NPV).

  Baseline

• Visual Analog Scale (VAS-Anxiety Reassessment) score

  A single consolidated VAS score (0-10) representing the pain experienced during the administration of local anesthetic across all four pin sites. This VAS is administered immediately after the local anesthetic injections are completed. For anxiety-VAS cutoff value = 40: the VAS score is ≥40 in 81% of patients with anxiety (sensitivity); the VAS score is \<40 in 70% of patients without anxiety (specificity); 67% of patients with a VAS score ≥ 40 have anxiety (PPV); 82% of patients with a VAS score \<40 do not have anxiety (NPV).

  Hour 24

• Total Anesthetic Volume

  Documentation of the total volume (mL) of local anesthetic infused.

  Hour 6

Secondary Outcomes (1)

• Number of Clinically Significant Vasovagal Episodes

  Hour 6

Study Arms (2)

Acetaminophen

ACTIVE COMPARATOR

acetaminophen (1000 mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.

Drug: acetaminophen

Suzetrigine

EXPERIMENTAL

Suzetrigine (100mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.

Drug: Suzetrigine

Interventions

Suzetrigine DRUG

100mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.

Also known as: Journavx

Suzetrigine

acetaminophen DRUG

1000mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.

Also known as: Tylenol

Acetaminophen

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for a standard of care procedure requiring a stereotactic head frame to be placed

You may not qualify if:

• Patients not scheduled for a standard of care procedure requiring a stereotactic head frame to be placed will not be approached

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Stephen B Tatter, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Jenkins, BSN RN, CCRC

CONTACT

336.716.3842; Wendy.Jenkins@AdvocateHealth.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both suzetrigine and acetaminophen will be placed into identical opaque capsules. Suzetrigine capsules will be backfilled with an inert excipient to match the weight and sound of the acetaminophen capsules.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After study consent is obtained. Subjects will be randomized to one of two arms. Each arm contains a medication currently being used in stereotactic frame placement. Arm 1 will be Acetaminophen and Arm 2 will be Suzetrigine.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)