Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2025-12-16 @ 5:58 PM
Study NCT ID:
NCT04465357
Status:
None
Last Update Posted:
2022-10-05 00:00:00
First Post:
2020-07-07 00:00:00
Brief Title:
Efficacy of Erenumab on Functional Impact of Migraine
Sponsor:
Merle Diamond
Organization:
Diamond Headache Clinic
Study Overview
Official Title:
A Multicenter, Open Label Study Assessing the Efficacy of Erenumab on Functional Impact of Migraine
Status:
None
Status Verified Date:
2022-09
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:
This is a single group, multicenter, open-label study with a study population of patients who meet International Classification of Headache Disorders 3rd edition (ICHD-III) criteria for migraine with or without aura and have 4 to 20 migraine days per month. This is a single-group supportive care study with one arm and no masking. A maximum of 54 participants will be enrolled to study intervention. All participants in this single-group study will complete a 4-week run-in period. After the run-in period, eligible participants will be enrolled to study intervention and enter a 12-week treatment period.
Detailed Description:
This is a single group multicenter open-label study with a study population of patients who meet International Classification of Headache Disorders 3rd edition ICHD-III criteria for migraine with or without aura and have 4 to 20 migraine days per month This is a single-group supportive care study with one arm and no masking A maximum of 54 participants will be enrolled to study intervention All participants in this single-group study will complete a 4-week run-in period After the run-in period eligible participants will be enrolled to study intervention and enter a 12-week treatment period
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?:
True
Is an FDA AA801 Violation?:
None