Randomized Controlled Trial of Intradermal Injections of OnabotulinumtoxinA vs Saline for Trigeminal Neuralgia.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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
Locations
United States
California
Meredith Barad
RECRUITING
Stanford
Contact Information
Primary
Meredith Barad, MD
amberfu@stanford.edu
6507217218
Backup
Amber Fu
amberfu@stanford.edu
6507217218
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 20
Treatments
Experimental: OnabotulinumtoxinA
Intradermal injections will be placed in the affected trigeminal territories according to a specific facial map that we have developed.
Placebo_comparator: Saline
The same procedure will be followed as above, but saline will be injected instead of onabotA
Related Therapeutic Areas
Sponsors
Leads: Stanford University