NCT07525219

Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen

A Randomized Controlled Trial Comparing Suzetrigine and Acetaminophen for Reducing Pain During Local Anesthetic Infiltration and Head Frame Application

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Frame placement can be painful even with local numbing medicine. This study compares two oral medications-Suzetrigine (an FDA-approved (January 30, 2025) non-opioid, non-addictive medication used to treat moderate-to-severe acute pain in adults)) and acetaminophen (Tylenol)-to see which is more effective at reducing this pain. Both Tylenol and Suzetrigine are currently being used for pain prevention during head frame placement. This study is being conducted to determine if one offers greater relief than the other.

Conditions

• Analgesic Efficacy

Interventions

Type	Name	Description
DRUG	Suzetrigine	100mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
DRUG	acetaminophen	1000mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2026-04-13
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study