OnabotulinumtoxinA for Trigeminal Neuralgia

Launched by STANFORD UNIVERSITY · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called OnabotulinumtoxinA (commonly known as Botox) for people suffering from Trigeminal Neuralgia, a condition that causes severe facial pain. The trial compares OnabotulinumtoxinA to a placebo, which is a harmless saline solution, to see if it can help reduce the number of painful attacks people experience. The trial is currently recruiting participants, and it is open to both men and women aged 18 and older who have tried other medications without success and do not want or are not candidates for surgery.

To be eligible for this study, participants must have experienced at least 10 painful episodes per week and have been on a stable dose of their current medications for the last two weeks. Participants will need to attend regular in-person visits and be able to communicate in English. It's important to note that certain individuals, such as those who are pregnant or have specific types of nerve pain, cannot join this study. If you decide to participate, you will receive either the OnabotulinumtoxinA treatment or the placebo during the trial, and the researchers will monitor your progress to see how well the treatment works.

Gender

ALL

Eligibility criteria

• 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