Analgesic EfficacyPhase 3NCT07525219
Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen
A Phase 3 study testing Suzetrigine and acetaminophen in people with Analgesic Efficacy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Local anesthetic infiltration is a primary source of acute pain during stereotactic procedures. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Analgesic Efficacy
- What is being tested?
- Suzetrigine and acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2026to Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for a standard of care procedure requiring a stereotactic head frame to be placed
Who cannot join
- Patients not scheduled for a standard of care procedure requiring a stereotactic head frame to be placed will not be approached
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Wendy Jenkins, BSN RN, CCRC, 336-716-3842, Wendy.Jenkins@Advocatehealth.org
About this study
Official title: A Randomized Controlled Trial Comparing Suzetrigine and Acetaminophen for Reducing Pain During Local Anesthetic Infiltration and Head Frame Application
Local anesthetic infiltration is a primary source of acute pain during stereotactic procedures.
Read the 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
- Being tested
- Suzetrigine, acetaminophen
- Keywords
- procedural prophylaxis, anesthetic infiltration, stereotactic head frame
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
Also called Journavx
100mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
acetaminophenDrug
Also called Tylenol
1000mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Active comparator | acetaminophen (1000 mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure. Receives: Drug: acetaminophen |
| Suzetrigine | Experimental | Suzetrigine (100mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure. Receives: Drug: Suzetrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Hour 24
Total Anesthetic Volume
Documentation of the total volume (mL) of local anesthetic infused.
Measured: Hour 6
Secondary outcomes (1)
Number of Clinically Significant Vasovagal Episodes
Documentation of any vasovagal response characterized by loss of color, sweating, and/or nausea that requires rescue via raising the patient's legs to a height higher than their head.
Measured: Hour 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start22 Jun 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesic EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen B Tatter, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525219
- Sponsor's protocol ID
- IRB00146434
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Suzetrigine and Acetaminophen for Reducing Pain During Local Anesthetic Infiltration and Head Frame Application
- ClinicalTrials.gov ID
- NCT07525219
- Acronym / sponsor ID
- IRB00146434
- Conditions
- Analgesic Efficacy
- Keywords
- procedural prophylaxis, anesthetic infiltration, stereotactic head frame
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Active comparator | Drug: acetaminophenacetaminophen (1000 mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure. |
| Suzetrigine | Experimental | Drug: SuzetrigineSuzetrigine (100mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for a standard of care procedure requiring a stereotactic head frame to be placed
Key exclusion criteria (1 listed)
- Patients not scheduled for a standard of care procedure requiring a stereotactic head frame to be placed will not be approached
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuzetrigineAlso: Journavx100mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure. | Drug | Suzetrigine |
| acetaminophenAlso: Tylenol1000mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure. | Drug | Acetaminophen |
Primary outcome
Visual Analog Scale (VAS-Anxiety) score
Time frame: Baseline
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).
Visual Analog Scale (VAS-Infiltration) score
Time frame: Baseline
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).
Visual Analog Scale (VAS-Pin Tightening) score
Time frame: Baseline
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).
Visual Analog Scale (VAS-Anxiety Reassessment) score
Time frame: Hour 24
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).
Total Anesthetic Volume
Time frame: Hour 6
Documentation of the total volume (mL) of local anesthetic infused.
1 secondary outcome
Number of Clinically Significant Vasovagal Episodes
Time frame: Hour 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen B Tatter, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Suzetrigine and acetaminophen in people with Analgesic Efficacy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Jenkins, BSN RN, CCRC (336.716.3842, Wendy.Jenkins@AdvocateHealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS-Anxiety) score (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.