Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-04-25 @ 2:55 PM
Study NCT ID:
NCT04461795
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2020-07-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of AJOVY (Fremanezumab-vfrm) on Interictal Migraine Related Burden
Sponsor:
David True
Organization:
Study Overview
Official Title:
A Multicenter, Open Label Study Assessing the Efficacy of AJOVY (Fremanezumab-vfrm) on Interictal Migraine Related Burden
Status:
COMPLETED
Status Verified Date:
2022-04
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 study is being conducted to evaluate the efficacy and safety of AJOVY (fremanezumab-vfrm) on interictal migraine related burden in adults.
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 22 migraine days per month. This is a single-group supportive care study with one arm and no masking. A maximum of 40 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:
False
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?: