Status:
RECRUITING
OnabotulinumtoxinA for Trigeminal Neuralgia
Lead Sponsor:
Stanford University
Conditions:
Trigeminal Neuralgia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.
Detailed Description
This study will offer onabotulinumtoxin A (Botox) delivered intradermally into the region of pain for the patient with trigeminal neuralgia. Should they derive benefit from the procedure (as determine...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06216886
Start Date
June 1 2024
End Date
September 1 2026
Last Update
January 28 2025
Active Locations (1)
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1
Meredith Barad
Stanford, California, United States, 94304