💬In plain words
What the trial is, and whether it could suit you
A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
💊
What it tests
- OnabotulinumtoxinA 100 UNT [Botox]
- Sodium Chloride 0.9% for Injection, Preservative Free
Meredith Barad
Stanford, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky