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New hope for kids with chronic migraines: drug trial shows promise

NCT ID NCT03832998

Symptom relief Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether the drug erenumab can help prevent migraines in children (ages 6 to 12) and teenagers (ages 12 to 18) who have chronic migraines. About 284 participants received either the drug or a placebo. The main goal was to see if the drug reduced the number of migraine days per month more than the placebo did.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

284 people

The number who actually took part.

Started

Sep 2019

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study. * Participant's parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures. * History of migraine (with or without aura) for ≥ 12 months before screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) ICHD-3 specifications for pediatric migraine (participants aged less than 18 years), should be considered for the diagnosis of migraine. * History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the participant as migraine days per month in each of the 3 months prior to screening. * Migraine frequency: greater than or equal to 8 migraine days based on the eDiary data during the last 28 days of the baseline phase if more than 28 days in duration. * Headache frequency of greater than or equal to 15 headache days based on the eDiary data during the last 28 days of the baseline phase if more than 28 days in duration. * Demonstrated at least 80% compliance with the eDiary based on the last 28 days of the baseline period, if more than 28 days in duration (eg, completing eDiary items for at least 23 out of the last 28 days of the baseline phase). Key Exclusion Criteria: * History of cluster headache or hemiplegic migraine headache. * Chronic migraine with continuous pain, in which the participant does not have any pain free periods (of any duration) during the 1 month prior to screening. * No therapeutic response with greater than 3 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. No therapeutic response is defined as no reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally-accepted therapeutic dose(s) based on the investigator's assessment. * History of suicidal behavior or the participant is at risk of self-harm or harm to others. * History of major psychiatric disorder. Participants with anxiety disorder and/or mild major depressive disorder (Patient Health Questionnaire Modified for Adolescents \[PHQ-A\] score 9 for adolescents or based on medical judgement of the investigator for children) are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Participants must have been on a stable dose within the 3 months before the start of the baseline phase.

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Conditions

The condition(s) this trial relates to.

Headache migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

Contacts and locations

Locations

  • 4 Medical Clinical Solutions London

    Ilford, IG1 4HP, United Kingdom

  • 4 Medical Clinical Solutions Manchester

    Manchester, M27 8FF, United Kingdom

  • Alder Hey Childrens Hospital

    Liverpool, L12 2AP, United Kingdom

  • Algemeen Ziekenhuis Sint-Maarten

    Mechelen, 2800, Belgium

  • Arzneimittelforschung Leipzig GmbH

    Leipzig, 04107, Germany

  • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

    Palermo, 90134, Italy

  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz

    Miskolc, 3526, Hungary

  • Cafam

    Bogota, Cundinamarca, 111211, Colombia

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405, United States

  • Centrum Medyczne Hope Clinic Sebastian Szklener

    Lublin, 20-701, Poland

  • Centrum Medyczne Luxmed Spzoo

    Lublin, 20-109, Poland

  • Charite - Universitaetsmedizin Berlin, Campus Virchow

    Berlin, 13353, Germany

  • Chicago Headache Center and Research Institute

    Chicago, Illinois, 60657, United States

  • Child Neurology Consultants of Austin

    Austin, Texas, 78757, United States

  • Childrens Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Childrens Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1, Canada

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Childrens Mercy Hospital and Clinics

    Kansas City, Missouri, 64108, United States

  • Childrens National Health System

    Washington D.C., District of Columbia, 20010, United States

  • Childrens Specialty Group

    Norfolk, Virginia, 23507, United States

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Clinical Research Center Spzoo Medic-R Spolka Komandytowa

    Poznan, 61-731, Poland

  • Clinical Research Institute Inc

    Plymouth, Minnesota, 55441, United States

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Dent Neurosciences Research Center

    Amherst, New York, 14226, United States

  • Docteur Simona Sava

    Saint-Nicolas, 4420, Belgium

  • Dr Altmann Anna egyeni vallalkozo

    Budapest, 1026, Hungary

  • Dr Kenessey Albert Korhaz - Rendelointezet

    Balassagyarmat, 2660, Hungary

  • Dr Sekowska Leczenie Bolu

    Warsaw, 01-018, Poland

  • Evelina Childrens Hospital

    London, SE1 7EU, United Kingdom

  • FSBI Russian Children Clinical Hospital of the MoH RF

    Moscow, 119571, Russia

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133, Italy

  • Fondazione Istituto Neurologico Nazionale C Mondino IRCCS

    Pavia, 27100, Italy

  • Fundacion Cardiovascular de Colombia

    Bucaramanga, Santander Department, 681017, Colombia

  • Fundacion Centro de Investigacion Clinica

    Medellín, Antioquia, 050021, Colombia

  • Great Ormond Street Hospital for Children

    London, WC1N 3JH, United Kingdom

  • Helios Clinical Research Inc

    Burleson, Texas, 76028, United States

  • High Tech Medical Kft

    Budapest, 1027, Hungary

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima, 730-8518, Japan

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165, Italy

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338, Poland

  • Japanese Red Cross Kyoto Daiichi Hospital

    Kyoto, Kyoto, 605-0981, Japan

  • Josai Kids Clinic

    Nagoya, Aichi-ken, 451-0031, Japan

  • Josephson Wallack Munshower Neurology

    Indianapolis, Indiana, 46256, United States

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582, Japan

  • Kitami Clinic

    Sapporo, Hokkaido, 060-0004, Japan

  • Konan Medical Center

    Kobe, Hyōgo, 658-0064, Japan

  • Kumamoto City Hospital

    Kumamoto, Kumamoto, 862-8505, Japan

  • LLC Medical Technologies

    Saint Petersburg, 191025, Russia

  • LLC Sibneyromed

    Novosibirsk, 630004, Russia

  • LLC clinic Chaika

    Moscow, 125047, Russia

  • London Health Sciences Centre

    London, Ontario, N6A 4G5, Canada

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449, United States

  • Medical Corporation Seikokai Takanoko Hospital

    Matsuyama, Ehime, 790-0925, Japan

  • Mercy Research

    St Louis, Missouri, 63141, United States

  • Meridian Clinical Research LLC

    Hastings, Nebraska, 68901, United States

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan, 48104, United States

  • Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, 52-210, Poland

  • Modern Migraine MD

    New York, New York, 10001, United States

  • Nagamitsu Clinic

    Hofu-shi, Yamaguchi, 747-0802, Japan

  • Nagaseki Headache Clinic

    Kai-shi, Yamanashi, 400-0124, Japan

  • Nationwide Childrens Hospital

    Columbus, Ohio, 43205, United States

  • New England Institute for Clinical Research

    Stamford, Connecticut, 06905, United States

  • New England Regional Headache Center Inc

    Worcester, Massachusetts, 14226, United States

  • Next Stage Spzoo

    Warsaw, 02-121, Poland

  • Nicklaus Childrens Hospital

    Miami, Florida, 33155, United States

  • Noahs Ark Childrens Hospital for Wales

    Cardiff, CF14 4XW, United Kingdom

  • Northwest Florida Clinical Research Group Limited Liability Company

    Gulf Breeze, Florida, 32561, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Oxford Childrens Hospital

    Oxford, OX3 9DU, United Kingdom

  • Palmetto Gastroenterology Clinical Research, LLC

    Summerville, South Carolina, 29486, United States

  • Paradigm Clinical Research Center Inc

    San Diego, California, 92108, United States

  • Pediatric Epilepsy and Neurology Specialists

    Tampa, Florida, 33609, United States

  • Preferred Primary Care Physicians, Inc

    Pittsburgh, Pennsylvania, 15236, United States

  • Premiere Research Institute

    West Palm Beach, Florida, 33407, United States

  • Puerto Rico Health and Wellness Institute

    Dorado, 00646, Puerto Rico

  • Rare Disease Research Center Pediatrics

    Atlanta, Georgia, 30329, United States

  • Royal Hospital for Children

    Glasgow, G51 4TF, United Kingdom

  • Saitama Neuropsychiatric Institute

    Saitama-shi, Saitama, 338-8577, Japan

  • Schmerzklinik Kiel

    Kiel, 24149, Germany

  • Semmelweis Egyetem

    Budapest, 1094, Hungary

  • Sendai Headache and Neurology Clinic

    Sendai, Miyagi, 982-0014, Japan

  • Stollery Childrens Hospital

    Edmonton, Alberta, T6G 1C9, Canada

  • Stryde Consulting LLC

    Frisco, Texas, 75033, United States

  • Tatsuoka Neurology Clinic

    Kyoto, Kyoto, 600-8811, Japan

  • Terveystalo Pulssi

    Turku, 20100, Finland

  • The Hospital For Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Tokyo Headache Clinic

    Shibuya-ku, Tokyo, 151-0051, Japan

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023, Japan

  • Tominaga Hospital

    Osaka, Osaka, 556-0017, Japan

  • TrueBlue Clinical Research

    Brandon, Florida, 33511, United States

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitair Ziekenhuis Brussel

    Brussels, 1090, Belgium

  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201, United States

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-355, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • Vaught Neurological Services

    Crab Orchard, West Virginia, 25827, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.