Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-08 @ 8:16 PM
Study NCT ID:
NCT03217968
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2017-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Abortive Treatment of Migraine With the Cefaly® Abortive Program Device
Sponsor:
Cefaly Technology
Organization:
Study Overview
Official Title:
Abortive Treatment of Migraine With the Cefaly® Abortive Program Device: Pilot Trial
Status:
COMPLETED
Status Verified Date:
2018-07
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:
The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This open clinical trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to development of a sham-controlled trial.
Detailed Description:
The main objective of this study is to have a pilot assessment of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. That is to say having pilot data to assess the efficacy of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: