Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 7:00 PM
Study NCT ID:
NCT05730556
Status:
TERMINATED
Last Update Posted:
2025-10-27
First Post:
2023-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Remote Electrical Neuromodulation for Acute Procedural Pain
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Remote Electrical Neuromodulation for Acute Procedural Pain in Chronic Migraine Patients Receiving onabotulinumtoxinA
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enough data was collected to demonstrate device efficacy at interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the effectiveness of using remote electrical neuromodulation, using the Nerivio ® device, to relieve pain associated with receiving onabotulinumtoxinA (Botox) injections for chronic migraine prevention.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: