Using Botox to treat Trigeminal Neuralgia
Randomized Controlled Trial of Intradermal Injections of OnabotulinumtoxinA vs Saline for Trigeminal Neuralgia.
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 |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT06216886 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with secondary or idiopathic trigeminal neuralgia, neuromuscular diseases, or those currently pregnant or breastfeeding may not benefit from this study.
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 performed: Other studies have shown promising results with Botox for various pain conditions, suggesting potential success for this approach in treating trigeminal neuralgia.
Eligibility criteria
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 this trial is running
Stanford, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.