NCT06216886PHASE4Recruiting
OnabotulinumtoxinA for Trigeminal Neuralgia
Stanford University
Start Date
6/1/2024
Completion Date
9/1/2027
Summary
A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.
Detailed 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.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DRUG
OnabotulinumtoxinA 100 UNT [Botox]
DRUG
Sodium Chloride 0.9% for Injection, Preservative Free
Conditions
Trigeminal Neuralgia
Locations
Meredith Barad
Stanford, California 94304
United States