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Study of Eptinezumab Given Intravenously for Prevention of Chronic Migraine in Adolescents Aged 12-17 Years

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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 young people aged 12 to 17 who have chronic migraine, a condition where headaches occur frequently and significantly impact daily life. The research evaluates a medication called eptinezumab (also known as VYEPTI), which is given through intravenous administration (directly into a vein). The purpose is to determine if this treatment can reduce the number of days that young patients experience migraines compared to those receiving a placebo.

The study medication or placebo will be given as an infusion solution that is administered into a vein. The treatment period lasts for 12 weeks, during which participants will receive the study medication or placebo. The study uses a method called "double-blind," which means neither the participants nor the doctors know who receives which treatment during the study.

Throughout the study, participants will need to keep track of their migraine days using an electronic diary. The researchers will monitor how the treatment affects migraine frequency and will also check for any changes in how often patients need to use other migraine medications. They will also evaluate how the treatment impacts the participants' daily activities and overall quality of life.

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

    During the first 28 days, you will need to complete a headache electronic diary (eDiary) for at least 23 out of 28 days

    The diary will help track your headache days (between 15-26 days) and migraine days (at least 8 days)

  2. Step 2

    Treatment phase start

    You will be randomly assigned to receive either VYEPTI (eptinezumab) or placebo (salt water solution)

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

  3. Step 3

    Monitoring period

    The study will track your progress for 12 weeks

    You will continue using the electronic diary to record your migraine days

    Your use of other migraine medications will be monitored

    You will complete a PedMIDAS questionnaire to assess how migraines affect your daily activities

  4. Step 4

    Medical assessments

    Blood samples will be taken to measure the concentration of the medication in your body

    Tests will be conducted to check for antibodies your body might produce in response to the medication

  5. Step 5

    Study completion

    The study will evaluate how the treatment affected your number of monthly migraine days

    The results will be compared between participants who received VYEPTI and those who received placebo

Who can join the trial?

7 criteria

  • Must be between 12 and 17 years old
  • Must have been diagnosed with migraine (with or without warning signs) for at least 6 months before the first study visit
  • Must be able to complete an electronic headache diary for at least 23 out of 28 days during the screening period
  • Must experience between 15 and 26 headache days during the 28-day screening period
  • At least 8 days of those headaches must be migraine headaches, recorded in the electronic diary
  • Both males and females can participate
  • Must be willing to use an electronic diary to record headache information

Who cannot join the trial?

12 criteria

  • Age below 12 years or above 17 years
  • Less than 15 headache days per month, of which at least 8 are migraine days (days when you experience migraine symptoms)
  • Previous treatment with eptinezumab (the study medication)
  • History of severe allergic reactions to any medications
  • Current diagnosis of other types of chronic headaches
  • Serious medical conditions affecting heart, liver, or kidneys
  • Current pregnancy or breastfeeding
  • Use of other preventive migraine medications within 2 months before the study
  • Participation in other clinical trials within the last 30 days
  • History of substance abuse in the past year
  • Mental health conditions that could interfere with study participation
  • Inability to follow study procedures or complete required documentation
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Investigated drugs

Eptinezumab is a medication given through an intravenous (IV) infusion to prevent chronic migraines. It belongs to a class of medications that target a protein in the body involved in migraine development. The medication works by reducing the frequency of migraine headaches in patients who experience them regularly. Normal saline solution (placebo) is used as a comparison in this study to determine how well eptinezumab works. This is a standard medical solution made of sterile water and salt that has no active medication in it.

What is already known about the treatment

Eptinezumab – A humanized monoclonal antibody administered through intravenous infusion, specifically designed for the preventive treatment of chronic migraine in adolescents aged 12-17 years. The medication works by targeting and inhibiting the calcitonin gene-related peptide (CGRP), a protein involved in pain transmission and inflammation during migraine attacks. As a member of the anti-CGRP antibody class of medications, eptinezumab represents a newer generation of migraine prevention treatments that has shown promising results in clinical trials, offering a potential alternative for young patients who suffer from frequent migraines.

Investigated diseases

Migraine - A neurological condition characterized by recurring headaches that typically affect one side of the head and are accompanied by various symptoms. The pain is usually throbbing or pulsating in nature and can last from several hours to days. Migraine episodes often come with additional symptoms such as sensitivity to light, sound, and certain smells, as well as nausea and vomiting. In some cases, people experience visual disturbances called aura before or during the headache phase. Chronic migraine occurs when a person experiences headaches on 15 or more days per month, with at least 8 being migraines, for more than three months. The condition can significantly affect daily activities and quality of life during attacks.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-510656-13-00Protocol code19356AEstimated enrolment339 patientsSponsorH. Lundbeck A/S

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