OnabotulinumtoxinA for Trigeminal Neuralgia

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • OnabotulinumtoxinA 100 UNT [Botox]
  • Sodium Chloride 0.9% for Injection, Preservative Free

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators