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Taking people in MexicoPhase 3

Eptinezumab infusions to prevent chronic migraine in teenagers

Tests eptinezumab against placebo for preventing migraine days in teenagers with chronic migraine.

Key facts

Who runs it
H. Lundbeck A/S
Where
Chihuahua City, Culiacán, Durango, Guadalajara, México, Monterrey, Morelia, Tepetlacolco, and Zapopan, MexicoSee the 9 sitesAlso in 10 other countries, 73 sites
Registry title
A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
Status
Recruiting
Phase
Phase 3
People taking part
285 people, planned
Started
30 Jun 2021
Expected to end
26 Mar 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Eptinezumab
  • Placebo
Record updated
16 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for young people aged 12 to 17 who have had chronic migraine for at least 6 months.

Age
12 to 17 years
Sex
All sexes can join.
Disease stage
Migraine (with or without aura) with a history of chronic migraine for at least 6 months before screening. In the 28-day screening period: 15 to 26 headache days, at least 8 of them migraine days.
Earlier treatment
Cannot have had any monoclonal antibody treatment or another CGRP antibody in the 6 months before screening. Cannot have had eptinezumab in this study before.

Main reasons for not taking part

  • Took part in this study before and received eptinezumab
  • Any monoclonal antibody treatment less than 6 months before screening
  • Another CGRP antibody less than 6 months before screening
  • History of complicated migraine, chronic tension-type headache, cluster headache or other listed headache types
  • Unusual migraine types such as hemiplegic migraine or migraine with brainstem aura

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit
  • During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit
  • During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary

Who cannot take part

  • The participant has previously been randomised in this study and exposed to eptinezumab
  • The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the screening visit
  • The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) <6 months prior to the screening visit
  • The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example >60 minutes)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 12 and 17 years old?

Where in Mexico

Also in 10 other countries, 73 sites

  • Icaro Investigaciones en Medicina S.A. de C.V.Chihuahua City, MexicoTaking people
  • Neurociencias Estudios Clinicos S.C.Culiacán, MexicoNo longer taking part
  • Instituto de Investigaciones Clinicas para la Salud A.C. (IICS A.C)Durango, MexicoTaking people
  • Centro de Investigacion Medico Biologica y Terapia Avanzada S.C. (CIMBYTA)Guadalajara, MexicoTaking people
  • Unidad de Investigación en Salud de Chihuahua S.C.México, MexicoNo longer taking part
  • Centro de Estudios Clinicos y Especialidades Medicas SCMonterrey, MexicoNo longer taking part
  • Centro de Investigacion Clinica de Morelia, S.C.Morelia, MexicoNo longer taking part
  • Clinical Research Institute SC-MexicoTepetlacolco, MexicoTaking people
  • Unidad de Investigación en Salud de Chihuahua S.C.Zapopan, MexicoNo longer taking part

About the trial

What the trial wants to find out

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

The 3 groups in the trial

  • Eptinezumab 300 mgTreatment being tested

    Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted).

    Treatment: Eptinezumab

  • Eptinezumab 100 mgTreatment being tested

    Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).

    Treatment: Eptinezumab

  • PlaceboPlacebo, for comparison

    Participants will receive a single IV infusion of placebo matching to eptinezumab.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine
Plain-language title
Eptinezumab infusions to prevent chronic migraine in teenagersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04965675, who can take part
Record updated
16 October 2026