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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Clinico San Carlos Madrid Spain
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal

Other Sites

Site Name City Country Status
Etg Neuroscience Sp. z o.o. Warsaw Poland
IRCCS Istituto Giannina Gaslini Genoa Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Mtz Clinical Research Powered By Pratia Warsaw Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Athleticomed Sp. z o.o. Bydgoszcz Poland
Azienda Socio Sanitaria Locale N. 8 Di Cagliari Cagliari Italy
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Alvaro Cunqueiro Vigo Spain
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centrum Leczenia MIGRE Wroclaw Poland
Ecj Ldjboe Lublin Poland
Ctlgku Hjwoiwqklg E Uzmwbscigucyv De Cbwrchx Eedgir Coimbra Portugal
Hkitojpb Vybm drvqerrs Barcelona Spain
Ixtbksqs Zlahpae Do Bypyfhpyjbjelhffd Oświęcim Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
08.11.2022
Poland Poland
Recruiting
08.11.2022
Portugal Portugal
Recruiting
08.11.2022
Spain Spain
Recruiting
08.11.2022

Trial locations

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.

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 ID:
2024-510656-13-00
Protocol code:
19356A
NCT ID:
NCT04965675
Trial Phase:
Therapeutic confirmatory (Phase III)

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