Recruiting

OnabotulinumtoxinA

Sponsor:

Stanford University

Code:

NCT06216886

Conditions

Trigeminal Neuralgia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OnabotulinumtoxinA 100 UNT [Botox]

Sodium Chloride 0.9% for Injection, Preservative Free

Study Details

Brief summary:

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

Conditions

Trigeminal Neuralgia

Study ID

NCT06216886

Start date

Jun 1, 2024

Status verified date

Jan, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OnabotulinumtoxinA

Intradermal injections will be placed in the affected trigeminal territories according to a specific facial map that we have developed.

placebo comparator: Saline

The same procedure will be followed as above, but saline will be injected instead of onabotA

Interventions

OnabotulinumtoxinA 100 UNT [Botox]

Intradermal injections will be placed in 25 unit aliquots allocated per affected trigeminal distribution. For example, if the target is the V1 territory, then the patient would get 25 units injected into the V1 distribution. This would be divided into 2.5 units per injection in 10 injection sites as outlined on the map. If V1/V2 were affected, the patient would get 50 units of onabotA. Maximum dose of 75 units if all three trigeminal distributions are involved. We have developed a specific map for administering the doses and this will be followed.

Sodium Chloride 0.9% for Injection, Preservative Free

intradermal injections will be placed in 25 unit aliquots allocated per affected trigeminal distribution. For example, if the target is the V1 territory, then the patient would get 25 units injected into the V1 distribution. This would be divided into 2.5 units per injection in 10 injection sites as outlined on the map. If V1/V2 were affected, the patient would get 50 units of saline. Maximum dose of 75 units if all three trigeminal distributions are involved. We have developed a specific map for administering the doses and this will be followed.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Meredith Barad, MD

6507217218nlariyos@stanford.edu

Natali Ariyoshi

6504978821nlariyos@stanford.edu

Locations

Meredith Barad

Recruiting

Stanford, California, United States, 94304

Contacts

Meredith Study Team

650-721-7218mbarad@stanford.edu

Principal Investigator:

Meredith Barad, MD

More Information

Sponsor

Stanford University

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

  • botox
  • injection
  • trigeminal neuralgia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-01-22.