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OnabotulinumtoxinA for Trigeminal Neuralgia

This study is testing if OnabotulinumtoxinA (Botox) can help people with Trigeminal Neuralgia (a condition causing severe facial pain). You may be able to join if you are 18 or older, have tried at least two medications without enough relief, and are not a candidate for or do not want surgery. The study will compare OnabotulinumtoxinA to a saline (saltwater) placebo. Success will be measured by how much the number of Trigeminal Neuralgia attacks per week changes after treatment. The study aims to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is a randomized controlled trial comparing OnabotulinumtoxinA to saline (placebo). It plans to enroll 20 participants.
What's involved
You would receive intradermal injections of either OnabotulinumtoxinA or saline. You would be followed for 3 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06216886

OnabotulinumtoxinA for Trigeminal Neuralgia

Recruiting
PHASE4Ages 18+InterventionalTreatment
Stanford University
~20 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:OnabotulinumtoxinA 100 UNT [Botox]Sodium Chloride 0.9% for Injection, Preservative Free

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Number of TN Attacks per week
Measured over compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment))

Conditions

Trigeminal Neuralgia

Explore related trials

Trigeminal neuralgia

NCT06216886

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Meredith Barad

    Stanford, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Meredith Barad, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Meredith Barad, MD
[email protected]
6507217218
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Number of TN Attacks per weekcompare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment))

    Frequency of TN attacks before and after onabotA injection over a seven day period