Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216886
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-01-11
Brief Title:
OnabotulinumtoxinA for Trigeminal Neuralgia
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Randomized Controlled Trial of Intradermal Injections of OnabotulinumtoxinA vs Saline for Trigeminal Neuralgia
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized controlled trial comparing Onabotulinumtoxin A to saline placebo for Trigeminal Neuralgia
Detailed Description:
This study will offer onabotulinumtoxin A Botox delivered intradermally into the region of pain for the patient with trigeminal neuralgia Should they derive benefit from the procedure as determined by decrease in the frequency of attacks then they will be randomized to receive either onabotulinumtoxin A or saline and followed for 3 months This study hopes to provide strong data that this is a treatment option for patients with TN who have failed medications but are not ready for or do not want to undergo surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None