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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | February 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT06216886 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
- Principal investigator: Meredith Barad, MD — Stanford University
- Study coordinator: Meredith Barad, MD
- Email: nlariyos@stanford.edu
- Phone: 6507217218
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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RP-008 with daily varenicline for trigeminal neuralgia
A new treatment approach tests RP-008 together with varenicline to see if it is safe, tolerable, and offers pain relief for adults with trigeminal neuralgia.
-
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This study is trying to see how different factors affect the results of brain surgeries by collecting information from patients before and after their operations.
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Comparing two methods for treating facial pain from trigeminal neuralgia
This study is testing whether a new combination of treatments for facial pain from trigeminal neuralgia works better than a single treatment to help adults feel less pain and improve their daily life.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.