Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920331
Status:
WITHDRAWN
Last Update Posted:
2022-02-22
First Post:
2021-06-03
Brief Title:
Study of Intravenous Erenumab in Patients With Status Migrainosus
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
STATUS STUDY Pilot Open-Label Trial of Intravenous Erenumab in Patients With Status Migrainosus
Status:
WITHDRAWN
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No Participants Enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will evaluate the efficacy for use of intravenous erenumab 140mg for treatment of status migrainosus in an open-label pilot study
Detailed Description:
This will be a single-center open-label pilot study The investigators will enroll 15 subjects Subjects will be recruited from the outpatient Mayo Headache Clinic The Headache Clinic employs 5 headache specialists and 1 fellow which is sufficient staffing to support this study and recruitment of patients with status migrainosus
Subject participation would be for a total of 28 days Subjects will be screened at outpatient clinic visit appointments or when they call into the clinic regarding an episode of status migrainosus and interested qualified subjects will be consented and offered participation in this trial
Once consent has been obtained subjects will have evaluation of vital signs pregnancy status complete blood count and comprehensive metabolic panel Abnormal metabolic profile kidney or liver function will exclude subjects Pregnancy will exclude subjects Qualifying subjects will be administered a single dose of intravenous erenumab at our Infusion Center at the first available appointment within 24 hours of qualifying for participation if they continue to have moderate to severe pain and monitored on-site for a minimum of 2 hours after start of drug administration
Subjects will fill out two headache diaries following treatment The first diary is an hourly diary with entries once every hour for 24 hours with time point 0 defined as time of when treatment begins Diary entry at hour 24 coincides with the time point for post-treatment day 1 Follow-up will occur by phone at post-treatment day 1 If pain and symptoms persist patients will be directed to contact their primary headache provider to receive further management From this point and onwards patients will be instructed to fill out a second diary once daily for 28 consecutive calendar days following treatment A final visit will be conducted at the end of the study at 28 days
Subject participation would be for a total of 28 days Subjects will be screened at outpatient clinic visit appointments or when they call into the clinic regarding an episode of status migrainosus and interested qualified subjects will be consented and offered participation in this trial
Once consent has been obtained subjects will have evaluation of vital signs pregnancy status complete blood count and comprehensive metabolic panel Abnormal metabolic profile kidney or liver function will exclude subjects Pregnancy will exclude subjects Qualifying subjects will be administered a single dose of intravenous erenumab at our Infusion Center at the first available appointment within 24 hours of qualifying for participation if they continue to have moderate to severe pain and monitored on-site for a minimum of 2 hours after start of drug administration
Subjects will fill out two headache diaries following treatment The first diary is an hourly diary with entries once every hour for 24 hours with time point 0 defined as time of when treatment begins Diary entry at hour 24 coincides with the time point for post-treatment day 1 Follow-up will occur by phone at post-treatment day 1 If pain and symptoms persist patients will be directed to contact their primary headache provider to receive further management From this point and onwards patients will be instructed to fill out a second diary once daily for 28 consecutive calendar days following treatment A final visit will be conducted at the end of the study at 28 days
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?:
None
Is an FDA AA801 Violation?:
None