OnabotulinumtoxinA for Trigeminal Neuralgia
Randomized Controlled Trial of Intradermal Injections of OnabotulinumtoxinA vs Saline for Trigeminal Neuralgia.
Stanford University
20 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
Summary
A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.
Eligibility
Inclusion Criteria9
- 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 Criteria5
- 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
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06216886