RightFit
RecruitingPhase 3

A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study includes a single intravenous (IV) infusion of the study drug and consists of a screening period (4 weeks), a double-blind, placebo-controlled period (12 weeks), and a safety follow-up period (8 weeks)."
  • "Participants confirmed eligible will be randomized (1:1:1) to receive a single IV infusion of either eptinezumab 300 milligrams (mg) dose (weight adjusted; targeting adult exposure after 300 mg IV), eptinezumab 100 mg (weight adjusted; targeting adult exposure after 100 mg IV), or placebo at randomization visit."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether eptinezumab lowers the number of migraine days better than a placebo (salt water with no study drug). It is for young people ages 12 to 17 with chronic migraine, which means frequent migraines over time.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 12 to 17 years old.
  • Have a migraine diagnosis that meets standard medical guidelines, with or without aura (warning signs such as changes in vision). Have had chronic migraine for at least 6 months before screening.
  • Fill out the electronic headache diary as required on at least 23 of the 28 days after the screening visit.
  • Record 15 to 26 headache days in the 28-day screening diary, including at least 8 migraine days.

Who can't join

  • Were already assigned to a group in this study and received eptinezumab.
  • Received any monoclonal antibody treatment (a type of medicine made from proteins) less than 6 months before screening, including in another study.
  • Received another CGRP antibody (a medicine that blocks a protein involved in migraine) less than 6 months before screening, including in another study.
  • Have or have had complicated migraine or certain other headache types: chronic tension-type headaches, headaches during sleep, cluster headaches, ongoing one-sided headaches, or new headaches that become daily and do not stop.
  • Have or have had unusual migraine types, including migraines with muscle weakness, brainstem aura (symptoms such as dizziness or trouble speaking), or trouble moving the eyes.
  • Have or have had migraines with symptoms not typical of aura, such as double vision, changes in awareness, or symptoms lasting more than 60 minutes.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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).

Study sites (22)

CT

DC

FL

GA

KY

MD

MI

NC

NY

OH

OK

  • University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Oklahoma Cancer Center · Oklahoma City, OK 73104-5418More trials in Oklahoma City

TX

VA

WA

  • MultiCare Mary Bridge Children's Hospital and Health Center · Tacoma, WA 98405-4234More trials in Tacoma

WV