Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Using Botox to treat Trigeminal Neuralgia

Official title: Randomized Controlled Trial of Intradermal Injections of OnabotulinumtoxinA vs Saline for Trigeminal Neuralgia.

Run by Stanford University · NCT06216886 · Data updated 2026-11-12

This study is testing if Botox can help people with trigeminal neuralgia who haven't found relief from other treatments by seeing if it reduces their pain attacks.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorStanford University
Academic / other
Locations1 site (Stanford, California)
StatusRecruiting
StartedJune 1, 2024
Main results expectedFebruary 1, 2027
Study endsSeptember 1, 2027
Registry record updatedJanuary 22, 2026
Trial IDNCT06216886 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 or older with a diagnosis of classical trigeminal neuralgia who have experienced inadequate relief from at least two medication trials.

Probably not a fit

Patients with secondary or idiopathic trigeminal neuralgia, neuromuscular diseases, or those currently pregnant or breastfeeding may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of onabotulinumtoxin A (Botox) for patients suffering from trigeminal neuralgia who have not found relief from medications and are not candidates for surgery. Participants will receive injections of Botox or a saline placebo in the area of pain, and their response will be monitored over a three-month period. The goal is to determine if Botox can significantly reduce the frequency of pain attacks in these patients.

Why it matters

Potential benefit: If successful, this treatment could provide a new non-surgical option for patients with trigeminal neuralgia who have not responded to traditional medications.

How similar studies have gone: Other studies have shown promising results with Botox for various pain conditions, suggesting potential success for this approach in treating trigeminal neuralgia.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Men and women age 18 or older

* Judged to be of legal competence
* Sufficient knowledge of written and spoken English
* Capable of attending regular in-person visits
* Have failed/not a candidate/do not want surgery
* Inadequate response to medication - at least 2 trials
* Meeting ICHD criteria for Classical Trigeminal Neuralgia 13.1.1.1
* Patients with frequency \> 10 attacks per week
* Stable dose of medications in the last 2 weeks

Exclusion Criteria:

* Secondary or Idiopathic TN, or Painful Trigeminal Neuropathy as defined by the ICHD (13.1.1.2, 13.1.1.3, 13.1.2)
* Pregnant or breast feeding (while it is rare that a patient will be pregnant with TN, there is not sufficient data to say definitively that onabotA is ok to use during pregnancy and nursing, it is still rated Class C)
* Neuromuscular disease
* On aminoglyocosides
* Not currently enrolled in any other studies

Where it's running

  • Meredith Barad
    Stanford, California, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.