OnabotulinumtoxinA for Trigeminal Neuralgia

Last updated: January 20, 2026
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

4

Condition

Trigeminal Neuralgia

Pain

Headaches

Treatment

Sodium Chloride 0.9% for Injection, Preservative Free

OnabotulinumtoxinA 100 UNT [Botox]

Clinical Study ID

NCT06216886
66036
  • Ages > 18
  • All Genders

Study Summary

A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.

Eligibility Criteria

Inclusion

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

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 withTN, there is not sufficient data to say definitively that onabotA is ok to useduring pregnancy and nursing, it is still rated Class C)

  • Neuromuscular disease

  • On aminoglyocosides

  • Not currently enrolled in any other studies

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Sodium Chloride 0.9% for Injection, Preservative Free
Phase: 4
Study Start date:
June 01, 2024
Estimated Completion Date:
September 01, 2027

Study Description

This study will offer onabotulinumtoxin A (Botox) delivered intradermally into the region of pain for the patient with trigeminal neuralgia. Should they derive benefit from the procedure (as determined by decrease in the frequency of attacks), then they will be randomized to receive either onabotulinumtoxin A or saline and followed for 3 months. This study hopes to provide strong data that this is a treatment option for patients with TN who have failed medications, but are not ready for or do not want to undergo surgery.

Connect with a study center

  • Meredith Barad

    Stanford, California 94304
    United States

    Site Not Available

  • Meredith Barad

    Stanford 5398563, California 5332921 94304
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.