Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07525219
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Analgesic Efficacy

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Acetaminophen
    acetaminophen (1000 mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
  • Experimental: Suzetrigine
    Suzetrigine (100mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.

Primary Outcome Measure

Visual Analog Scale (VAS-Anxiety) score [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Wendy Jenkins, BSN RN, CCRC
336-716-3842

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