Phase
Condition
Trigeminal Neuralgia
Pain
Headaches
Treatment
Sodium Chloride 0.9% for Injection, Preservative Free
OnabotulinumtoxinA 100 UNT [Botox]
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 withTN, there is not sufficient data to say definitively that onabotA is ok to useduring pregnancy and nursing, it is still rated Class C)
Neuromuscular disease
On aminoglyocosides
Not currently enrolled in any other studies
Study Design
Study Description
Connect with a study center
Meredith Barad
Stanford, California 94304
United StatesSite Not Available
Meredith Barad
Stanford 5398563, California 5332921 94304
United StatesActive - Recruiting

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