OnabotulinumtoxinA for Trigeminal Neuralgia (NCT06216886) | Clinical Trial Compass
RecruitingPhase 4
OnabotulinumtoxinA for Trigeminal Neuralgia
United States20 participantsStarted 2024-06-01
Plain-language summary
A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.
Who can participate
Age range18 Years
SexALL
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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 they're measuring
1
Change in Number of TN Attacks per week
Timeframe: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment))