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New treatment option for Trigeminal Neuralgia
Official title OnabotulinumtoxinA for Trigeminal Neuralgia
ClinicalTrials.gov ID: NCT06216886
What this study is testing
What is OnabotulinumtoxinA 100 UNT [Botox]?
OnabotulinumtoxinA 100 UNT [Botox] is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for trigeminal neuralgia.
Also referred to as Botox.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Neuromuscular disease
- On aminoglyocosides
- Not currently enrolled in any other studies
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.