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Eptinezumab for Migraine

Phase 3

Waitlist Available

Research Sponsored by Dr George Medvedev

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

No Placebo-Only Group

Pivotal Trial

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 below

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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:

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I am currently being treated for a systemic condition like vasculitis.

Select...

I have been treated with eptinezumab in the last 3 months.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of migraine days at week 1

Secondary study objectives

Generalized Anxiety Disorder 7-item (GAD-7)

Headache Impact Test (HIT-6)

Migraine recurrence

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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

~2200

0 / 6Eligibility criteria met