Eptinezumab treatment for adolescents with chronic migraine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of eptinezumab, administered as a single intravenous infusion, in reducing the number of migraine days in adolescents aged 12 to 17 with chronic migraine. Participants will be randomized to receive either eptinezumab at two different doses or a placebo over a 12-week period, following a 4-week screening phase. The study aims to determine if eptinezumab is superior to placebo in managing chronic migraines in this age group. Safety will be monitored during an 8-week follow-up period after treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Where it's running

• New England Institute for Clinical Research (NEICR) - Stamford
  Stamford, Connecticut, United States Recruiting
• NW FL Clinical Research Group, LLC
  Gulf Breeze, Florida, United States Recruiting
• AGA Clinical Trials
  Hialeah, Florida, United States Recruiting
• University of South Florida (USF) - Tampa Campus
  Tampa, Florida, United States Recruiting
• UK HealthCare-Kentucky Clinic
  Lexington, Kentucky, United States Recruiting
• Cincinnati Children's Hospital Medical Center-Burnet Campus
  Cincinnati, Ohio, United States Recruiting

+29 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Email contact via H. Lundbeck A/S
• Email: HQ_Medinfo@Lundbeck.com
• Phone: +45 36301311

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Early Eptinezumab for Acute Post-Traumatic Headache

  This study tests whether a single infusion of eptinezumab can help people with acute post-traumatic headaches, particularly those with a migraine-like pattern, after a mild brain injury.

  Recruiting Phase 3 Sunnybrook Health Sciences Centre · Toronto, Ontario · NCT07191145

• Eptinezumab given during a migraine attack (BE-FREE)

  This will test whether an IV dose of eptinezumab can stop an ongoing migraine attack in people who have at least eight migraine days per month.

  Recruiting University of Florence · Roma · NCT06628921

• Eptinezumab for treating episodic migraine in children

  This study tests if a new medication called eptinezumab can help reduce the number of migraine days in children who have episodic migraines.

  Recruiting at 46 sites Phase 3 H. Lundbeck A/S · Stamford, Connecticut and 59 other locations · NCT05897320

• Assessing the effectiveness of eptinezumab for migraine treatment in real-world settings

  This study is testing how well eptinezumab, an IV treatment for migraines, works in real life for people who have frequent migraines and haven't had success with other treatments.

  Recruiting IRCCS San Raffaele Roma · Roma, RM · NCT05570149

• Long-term safety of eptinezumab for children and adolescents with migraines

  This study is testing the long-term safety of a migraine medication called eptinezumab in children and teens aged 6 to 17 who have chronic or episodic migraines.

  Recruiting at 54 sites Phase 3 H. Lundbeck A/S · New Haven, Connecticut and 63 other locations · NCT05164172

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.