OnabotulinumtoxinA for Trigeminal Neuralgia

PHASE4RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

February 1, 2026

Study Completion Date

September 1, 2026

Conditions
Trigeminal Neuralgia
Interventions
DRUG

OnabotulinumtoxinA 100 UNT [Botox]

Intradermal injections will be placed in 25 unit aliquots allocated per affected trigeminal distribution. For example, if the target is the V1 territory, then the patient would get 25 units injected into the V1 distribution. This would be divided into 2.5 units per injection in 10 injection sites as outlined on the map. If V1/V2 were affected, the patient would get 50 units of onabotA. Maximum dose of 75 units if all three trigeminal distributions are involved. We have developed a specific map for administering the doses and this will be followed.

DRUG

Sodium Chloride 0.9% for Injection, Preservative Free

intradermal injections will be placed in 25 unit aliquots allocated per affected trigeminal distribution. For example, if the target is the V1 territory, then the patient would get 25 units injected into the V1 distribution. This would be divided into 2.5 units per injection in 10 injection sites as outlined on the map. If V1/V2 were affected, the patient would get 50 units of saline. Maximum dose of 75 units if all three trigeminal distributions are involved. We have developed a specific map for administering the doses and this will be followed.

Trial Locations (1)

94304

RECRUITING

Meredith Barad, Stanford

All Listed Sponsors
lead

Stanford University

OTHER