NCT06216886 OnabotulinumtoxinA for Trigeminal Neuralgia
| NCT ID | NCT06216886 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Stanford University |
| Condition | Trigeminal Neuralgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2024-06-01 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.
Eligibility Criteria
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
Contact & Investigator
Meredith Barad, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT06216886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Trigeminal Neuralgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06216886 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06216886 currently recruiting?
Yes, NCT06216886 is actively recruiting participants. Contact the research team at nlariyos@stanford.edu for enrollment information.
Where is the NCT06216886 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT06216886 clinical trial?
NCT06216886 is sponsored by Stanford University. The principal investigator is Meredith Barad, MD at Stanford University. The trial plans to enroll 20 participants.