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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presenting to the emergency department with a migraine that meets ICHD-3 migraine headache criteria
Be older than 18 years old
Must not have
A systemic condition in the stage of active treatment (vasculitis, etc.)
Dosed with eptinezumab within the past 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 3
Awards & highlights
Summary
"This trial aims to investigate if a medication called eptinezumab given to patients in the Emergency Department can help prevent migraines from recurring. The study will assess if eptinezumab can
Who is the study for?
This trial is for patients who come to the Emergency Department with a migraine. It's designed to see if eptinezumab, given during their visit, can prevent future migraines. To join, individuals must have a diagnosis of migraine and be in need of emergency care.
What is being tested?
The study tests whether eptinezumab (Vyepti), when added to standard ED treatments for migraines, can stop migraines from returning shortly after treatment. The goal is also to see if it reduces return ED visits and improves overall well-being.
What are the potential side effects?
While specific side effects are not listed here, eptinezumab may cause reactions similar to other preventive migraine treatments such as injection site reactions or allergy symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in the ER for a migraine that fits specific medical criteria.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently being treated for a systemic condition like vasculitis.
Select...
I have been treated with eptinezumab in the last 3 months.
Select...
My headaches are due to a previous injury or illness like a concussion or infection.
Select...
I am currently receiving anti-CGRP therapy.
Select...
I have or had severe heart disease or kidney problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of migraine days at week 1
Secondary outcome measures
Generalized Anxiety Disorder 7-item (GAD-7)
Headache Impact Test (HIT-6)
Migraine recurrence
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Standard of Care + EptinezumabExperimental Treatment2 Interventions
In addition to standard of care, participants randomized to the Standard of Care + Eptinezumab arm will receive a single infusion of eptinezumab (100mg/mL).
Group II: Standard of CareExperimental Treatment1 Intervention
SoC will be delivered at the discretion of the treating physician
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eptinezumab
2021
Completed Phase 3
~2040
Find a Location
Who is running the clinical trial?
Dr George MedvedevLead Sponsor
1 Previous Clinical Trials
19 Total Patients Enrolled
H. Lundbeck A/SIndustry Sponsor
327 Previous Clinical Trials
77,599 Total Patients Enrolled
13 Trials studying Migraine
4,786 Patients Enrolled for Migraine
Centre for Neurology Studies, Surrey Neuroplasticity Clinic Inc.UNKNOWN
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