OnabotulinumtoxinA for Trigeminal Neuralgia

Stanford University

Status and phase: Enrolling; Phase 4

Conditions: Trigeminal Neuralgia

Treatments: Drug: OnabotulinumtoxinA 100 UNT [Botox]; Drug: Sodium Chloride 0.9% for Injection, Preservative Free

Study type: Interventional

Funder types: Other

Identifiers

NCT06216886

66036

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

OnabotulinumtoxinA

Experimental group

Description:

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

Treatment:

Drug: OnabotulinumtoxinA 100 UNT [Botox]

Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Sodium Chloride 0.9% for Injection, Preservative Free