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Study of Eptinezumab as Add-on Treatment for Prevention of Migraine in Adults with Both Migraine and Medication Overuse Headache

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people who have both chronic migraine and medication overuse headache. Medication overuse headache occurs when people frequently use headache medications, which can actually lead to more frequent headaches. The study will test a medicine called eptinezumab (also known as VYEPTI or Lu AG09221), which is given through an intravenous infusion for migraine prevention.

The purpose of this research is to determine if eptinezumab, when combined with basic education about headaches, can help prevent migraines and treat medication overuse headaches. During the study, participants will receive either eptinezumab or placebo as an addition to educational information about headache management. The medication or placebo will be given through an infusion into a vein.

The study will last for 72 weeks, during which participants may receive up to 300 milligrams of the study medication. Throughout the study, participants will need to keep track of their headaches and medication use in an electronic diary. The researchers will monitor how the treatment affects both the frequency of migraines and the overuse of headache medications.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening period

    You will need to keep a headache diary for 28 days using an electronic diary (eDiary)

    The diary must be completed for at least 24 out of 28 days to continue in the study

    During this time, your current headache patterns and medication use will be monitored

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either eptinezumab or a placebo

    Neither you nor your doctor will know which treatment you are receiving

    The medication will be given through an intravenous infusion (directly into your vein)

  3. Step 3

    First 4 weeks of treatment

    You will continue using the eDiary to record your headaches and medication use

    Your headache frequency and pain levels will be monitored

    The number of days you experience migraine headaches will be tracked

    Your use of acute headache medications will be recorded

  4. Step 4

    Weeks 5-12 of treatment

    Continued monitoring of your headache patterns through the eDiary

    Assessment of changes in your migraine frequency

    Tracking of your acute medication use

    Evaluation of whether you still meet the criteria for chronic migraine and medication overuse headache

  5. Step 5

    Final assessment

    Evaluation of changes in your headache patterns over the 12-week period

    Assessment of changes in your pain levels

    Review of changes in your medication use patterns

    Final determination of your migraine and medication overuse status

Who can join the trial?

10 criteria

  • You must be between 18 and 75 years old
  • You must have been diagnosed with chronic migraine (a condition where headaches occur on 15 or more days per month)
  • Your first migraine must have started when you were 50 years old or younger
  • You must have had migraines for at least 12 months before screening
  • You must have at least 8 migraine days per month in each of the last 3 months
  • You must have at least 15 headache days per month in each of the last 3 months
  • You must be regularly using medications for acute headache treatment for more than 3 months
  • You must have tried and failed at least one preventive treatment in the last 5 years
  • You must be diagnosed with medication overuse headache (headaches caused by frequent use of pain medications)
  • You must be willing to use an electronic diary to record your headaches and demonstrate compliance by completing entries for at least 24 out of 28 days

Who cannot join the trial?

14 criteria

  • Age below 18 or above 65 years
  • Pregnant or breastfeeding women
  • History of stroke or transient ischemic attack (temporary stroke-like symptoms) within the past 6 months
  • Current diagnosis of chronic pain conditions other than migraine
  • Use of botulinum toxin treatments for headache in the past 4 months
  • History of substance abuse or addiction within the past year
  • Presence of other serious medical conditions that could interfere with the study, including:
    • Severe heart disease
    • Uncontrolled high blood pressure
    • Severe kidney or liver problems
    • Current participation in other clinical trials
    • Known allergies to the study medication or its components
    • Mental health conditions that could affect the ability to provide accurate symptom reporting
    • Previous failure of three or more preventive migraine medications
    • Inability to comply with study procedures or follow-up visits
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Investigated drugs

  • Eptinezumab

    is a preventive medication for migraine treatment. It belongs to a class of drugs called CGRP inhibitors, which work by blocking a protein involved in causing migraine headaches. This medication is given as an intravenous infusion and is specifically designed to help people who suffer from both migraine headaches and medication overuse headache (a condition that occurs from using too many pain medications). The medication aims to reduce the frequency and severity of migraine attacks while helping patients who are using too many acute headache medications.

  • Brief Education Intervention (BI)

    is not a medication but rather a therapeutic approach that involves teaching patients about their condition and providing strategies to manage their headaches. This intervention includes education about migraine triggers, lifestyle modifications, and proper use of medications to prevent medication overuse headache.

What is already known about the treatment

Eptinezumab - A humanized monoclonal antibody administered through intravenous infusion, specifically designed for migraine prevention in adults, including those with medication overuse headache. This medication works by targeting and blocking the calcitonin gene-related peptide (CGRP), a protein involved in pain transmission and inflammation in the nervous system, thereby reducing the frequency and severity of migraine attacks. Eptinezumab belongs to the class of CGRP antagonists and represents a newer generation of preventive migraine treatments, with clinical studies showing effectiveness in reducing monthly migraine days and improving quality of life for patients with chronic migraine.

Investigated diseases

  • Chronic Migraine

    A neurological condition characterized by headaches occurring on 15 or more days per month for more than three months, with at least eight of those days featuring migraine symptoms. The pain typically affects one side of the head and may be accompanied by nausea, sensitivity to light and sound, and visual disturbances.

  • Migraine

    A neurological disorder characterized by recurring headaches that typically cause moderate to severe throbbing pain, usually on one side of the head. Episodes can last from several hours to days and are often accompanied by nausea, vomiting, and sensitivity to light and sound. Some people experience warning symptoms called aura before the headache begins.

  • Medication Overuse Headache

    A secondary headache disorder that develops as a result of regular, long-term use of headache medication. It occurs when pain relievers are taken for headaches 15 or more days per month. The condition creates a cycle where frequent use of pain medication leads to more frequent headaches, prompting increased medication use.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510729-24-00Protocol codeRESOLUTION 20007AEstimated enrolment815 patientsSponsorH. Lundbeck A/S

sourced from the EU Clinical Trials Register and site verification

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