Taking people in TürkiyePhase 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
- Eskişehir, Fatih, Istanbul, Izmir, and Mersin, TürkiyeSee the 5 sitesAlso in 10 other countries, 77 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 Türkiye
Also in 10 other countries, 77 sites
- Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)Eskişehir, TürkiyeTaking people
- Istanbul Universitesi - Cerrahpasa Tip Fakultesi (Cerrahpasa Medical Faculty)Fatih, TürkiyeNo longer taking part
- Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) HastanesiIstanbul, TürkiyeTaking people
- İzmir Şehir HastanesiIzmir, TürkiyeTaking people
- Mersin Universitesi Tip FakultesiMersin, TürkiyeTaking people
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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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