Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a monthly shot stop migraines in kids?

NCT ID NCT03836040

Disease control 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This phase 3 study tests whether erenumab (Aimovig), a monthly injection already approved for adults, can prevent migraines in children aged 6 to 17 with episodic migraine. About 457 participants receive either the drug or a placebo for 3 months. The main goal is to see if the drug reduces the number of migraine days per month compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Erenumab (Aimovig)
What this could lead to
If successful, this could provide a new preventive treatment option for children and teens with frequent migraines, reducing the number of headache days.
What could go wrong
This is a late-stage trial, but results are not yet published. The drug may not work as well in younger patients, and side effects like injection-site reactions or constipation are possible.

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

457 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Nov 2026

An estimate. End dates often move.

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 greater than or equal to 12 months before screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) based on medical records and/or participant self-report or parents' or legal representative's report. * The following ICHD-3 specifications for pediatric migraine (participants aged less than 18 years), should be considered for the diagnosis of migraine: * Attacks may last 2 to 72 hours. * Migraine headache is more often bilateral than in adults; unilateral pain usually emerges in late adolescence or early adult life. * Migraine headache is usually frontotemporal. Occipital headache in children is rare and calls for diagnostic caution. * A subset of otherwise typical participants have facial location of pain, which is called 'facial migraine' in the literature; there is no evidence that these participants form a separate subgroup of migraine participants. * In young children, photophobia and phonophobia may be inferred from their behavior. * History of less than 15 headache days per month of which greater than or equal to 4 headache days were assessed by the participant as migraine days in each of the 3 months prior to screening (refer to Section 5.6 for definition of migraine day). * Criteria to be assessed prospectively during the 4-week baseline phase and confirmed before randomizing the participant into the DBTP: * Migraine frequency: greater than or equal 4 and less than 15 migraine days based on the eDiary data during the last 28 days of the baseline phase if greater than 28 days in duration * Headache frequency: less than 15 headache days based on the eDiary data during the last 28 days of the baseline phase if greater than 28 days in duration. * Demonstrated at least 80% compliance with the eDiary based on the last 28 days of the baseline period, if greater than 28 days in duration (eg, completing eDiary items for at least 23 out of the last 28 days of the baseline phase). * Exclusion Criteria • History of cluster headache or hemiplegic migraine headache. * No therapeutic response with greater than 2 of the following 10 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. These medication categories are: * Category 1: beta blockers (eg, propranolol, atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, timolol) * Category 2: tricyclic antidepressants (eg, amitriptyline, nortriptyline, protriptyline) * Category 3: topiramate * Category 4: divalproex sodium, sodium valproate * Category 5: serotonin-norepinephrine reuptake inhibitors (eg, venlafaxine, desvenlafaxine, duloxetine, milnacipran) * Category 6: cyproheptadine * Category 7: flunarizine, cinnarizine * Category 8: botulinum toxin * Category 9: lisinopril/candesartan * Category 10: medications targeting the CGRP pathway. * 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. * The following scenarios do not constitute lack of therapeutic response: * Lack of sustained response to a medication. * Partial, suboptimal response to a medication. * Failure to tolerate a therapeutic dose. * Evidence of drug or alcohol abuse or dependence within 12 months before screening, based on medical records, participant self-report, or positive urine drug test performed during screening (with the exception of prescribed medications such as opioids or barbiturates). * Human immunodeficiency virus (HIV) infection by history. * History of seizure disorder or other significant neurological disorder other than migraine. Note: a single childhood febrile seizure is not exclusionary. * History of major psychiatric disorder (such as schizophrenia, schizoaffective disorder, bipolar disorder, obsessive-compulsive disorder, or pervasive developmental disorder), or current evidence of major depressive disorder based on a patient health questionnaire-9 modified for adolescents (PHQ-A) score greater than or equal to 10 at screening. Participants with anxiety disorder and/or mild major depressive disorder (with PHQ-A score ≤ 9) 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. Participant must have been on a stable dose within the 3 months before the start of the baseline phase. * Use of prohibited medication within 1 month before the start of the baseline phase and/or during the baseline phase. * Use of prohibited devices (such as stimulation devices) or procedures (such as acupuncture, biofeedback, relaxation techniques, or psychotherapy) with the goal of preventing migraines, within 3 months before the start of the baseline phase and/or during the baseline phase. * Participants receiving Cognitive Behavioral Therapy (CBT) are excluded unless they are on a stable, maintenance phase of a CBT program for migraine for at least 3 months before the start of the baseline phase. Participants undergoing CBT are considered on a stable, maintenance phase if they have undergone greater than or equal 6 weekly or biweekly sessions of CBT administered by adequately trained psychologists and who, for at least 3 months before the start of the baseline phase, only follow "booster" CBT sessions at a monthly, bimonthly or quarterly frequency. Note: Participants who have discontinued CBT within 3 months prior to the start of the baseline phase are eligible for the study provided that there is evidence of CBT failure/lack of efficacy prior to initial screening (per medical records or investigator's assessment). * Received botulinum toxin in the head and/or neck region within 4 months before the start of the baseline phase or during the baseline phase. * Received medication targeting the CGRP pathway within 4 months before the start of the baseline phase or during the baseline phase. * Taken the following for any indication in any month during the 2 months before the start of the baseline phase, or during the baseline phase: * Ergotamines or triptans on greater than or equal 10 days per month. * Simple analgesics (nonsteroidal anti-inflammatory drugs \[NSAIDs\], acetaminophen) on greater than or equal 15 days per month. * Opioid or butalbital-containing analgesics on greater than or equal 4 days per month. * Currently receiving treatment in another investigational device or drug study, or less than 90 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. * Participant has clinically significant vital signs, laboratory results, or ECG abnormality during screening that, in the opinion of the investigator, could pose a risk to participant safety or interfere with the study evaluation. * Hepatic disease by history or total bilirubin (TBL) greater than or equal 2.0 x upper limit of normal (ULN) or alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than or equal 3.0 x ULN, as assessed by the central laboratory at initial screening. * Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during the study and for an additional 16 weeks after the last dose of investigational product. (Females of childbearing potential should only be included in the study after a confirmed menstrual period and a negative highly sensitive urine and serum pregnancy test.) * Female participants of childbearing potential unwilling to use an acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product. * Participant has known sensitivity to any of the products or components to be administered during dosing. * Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant's legal representative and investigator's knowledge. * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Migraine are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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 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

  • AthleticoMed

    Bydgoszcz, 85-752, Poland

  • 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

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinical Research Center Spzoo Medic-R Spolka Komandytowa

    Poznan, 61-731, Poland

  • Clinical Research Institute Inc

    Minneapolis, Minnesota, 55402, 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 Centro de Investigacion Clinica

    Medellín, Antioquia, 050021, Colombia

  • Fundacion Hospital Infantil Universitario De San Jose

    Bogota, Cundinamarca, 111221, Colombia

  • Fundacion cardiovascular de Colombia

    Bucaramanga, Santander Department, 681017, 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

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013, Spain

  • Hospital da Luz, SA

    Lisbon, 1500-650, Portugal

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041, Spain

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165, Italy

  • Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA

    Rionegro, Antioquia, 054040, Colombia

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338, Poland

  • Ishikawa Clinic

    Kyoto, Kyoto, 606-0851, Japan

  • 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

  • Kopfwehzentrum Hirslanden

    Zollikon, 8702, Switzerland

  • 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

  • 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

  • Servicios de Salud Ips Suramericana Sas - Ips Sura Industriales

    Medellín, Antioquia, 50021, Colombia

  • Solano y Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia Uniendo

    Bogota, Cundinamarca, 110221, Colombia

  • 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 Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023, Japan

  • Tominaga Hospital

    Osaka, Osaka, 556-0017, Japan

  • TrueBlue Clinical Research

    Tampa, Florida, 33612, United States

  • Umenotsuji Clinic

    Kochi, Kochi, 780-8011, Japan

  • Unidade Local de Saude de Coimbra, EPE - Hospital Pediatrico de Coimbra

    Coimbra, 3000-602, Portugal

  • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Unidade Local de Saude de Sao Jose, EPE - Hospital Dona Estefania

    Lisbon, 1169-045, Portugal

  • Universitaets-Kinderspital beider Basel

    Basel, 4031, Switzerland

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Greifswald

    Greifswald, 17475, Germany

  • Universitair Ziekenhuis Brussel

    Brussels, 1090, Belgium

  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201, United States

  • Uniwersytecki Dzieciecy Szpital Kliniczny im Ludwika Zamenhofa w Bialymstoku

    Bialystok, 15-274, Poland

  • 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

  • Velocity Clinical Research, Inc

    Grand Island, Nebraska, 68803, United States

More trials for these conditions

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