Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
NCT ID: NCT03832998
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
284 participants
INTERVENTIONAL
2019-09-05
2026-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dose Level 1
Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
Erenumab Dose 1
Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
Erenumab Dose 2
Participants in the low body-weight group at day 1 who are randomized to Dose Level 2 and participants in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
Dose Level 2
Participants will be randomized to one of two doses determined by their body-weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
Erenumab Dose 2
Participants in the low body-weight group at day 1 who are randomized to Dose Level 2 and participants in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
Erenumab Dose 3
Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
Placebo
Placebo
Placebo matching dose for erenumab dose 1, 2 and 3.
Interventions
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Erenumab Dose 1
Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
Erenumab Dose 2
Participants in the low body-weight group at day 1 who are randomized to Dose Level 2 and participants in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
Erenumab Dose 3
Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
Placebo
Placebo matching dose for erenumab dose 1, 2 and 3.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
6 Years
17 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Paradigm Clinical Research Center Inc
San Diego, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
Childrens National Health System
Washington D.C., District of Columbia, United States
TrueBlue Clinical Research
Brandon, Florida, United States
Northwest Florida Clinical Research Group Limited Liability Company
Gulf Breeze, Florida, United States
Nicklaus Childrens Hospital
Miami, Florida, United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Rare Disease Research Center Pediatrics
Atlanta, Georgia, United States
CenExel iResearch, LLC
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Chicago Headache Center and Research Institute
Chicago, Illinois, United States
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, United States
University of Maryland, Baltimore
Baltimore, Maryland, United States
New England Regional Headache Center Inc
Worcester, Massachusetts, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
Clinical Research Institute Inc
Plymouth, Minnesota, United States
Childrens Mercy Hospital and Clinics
Kansas City, Missouri, United States
Mercy Research
St Louis, Missouri, United States
Meridian Clinical Research LLC
Hastings, Nebraska, United States
Dent Neurosciences Research Center
Amherst, New York, United States
Modern Migraine MD
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nationwide Childrens Hospital
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, United States
Palmetto Gastroenterology Clinical Research, LLC
Summerville, South Carolina, United States
Child Neurology Consultants of Austin
Austin, Texas, United States
Helios Clinical Research Inc
Burleson, Texas, United States
Stryde Consulting LLC
Frisco, Texas, United States
Childrens Specialty Group
Norfolk, Virginia, United States
Vaught Neurological Services
Crab Orchard, West Virginia, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Algemeen Ziekenhuis Sint-Maarten
Mechelen, , Belgium
Docteur Simona Sava
Saint-Nicolas, , Belgium
Stollery Childrens Hospital
Edmonton, Alberta, Canada
London Health Sciences Centre
London, Ontario, Canada
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital For Sick Children
Toronto, Ontario, Canada
Fundacion Centro de Investigacion Clinica
Medellín, Antioquia, Colombia
Cafam
Bogota, Cundinamarca, Colombia
Fundacion Cardiovascular de Colombia
Bucaramanga, Santander Department, Colombia
Terveystalo Pulssi
Turku, , Finland
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Schmerzklinik Kiel
Kiel, , Germany
Arzneimittelforschung Leipzig GmbH
Leipzig, , Germany
Dr Kenessey Albert Korhaz - Rendelointezet
Balassagyarmat, , Hungary
Dr Altmann Anna egyeni vallalkozo
Budapest, , Hungary
High Tech Medical Kft
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, , Hungary
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, , Italy
Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
Pavia, , Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, , Italy
Josai Kids Clinic
Nagoya, Aichi-ken, Japan
Medical Corporation Seikokai Takanoko Hospital
Matsuyama, Ehime, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, Japan
Kitami Clinic
Sapporo, Hokkaido, Japan
Konan Medical Center
Kobe, Hyōgo, Japan
Kumamoto City Hospital
Kumamoto, Kumamoto, Japan
Tatsuoka Neurology Clinic
Kyoto, Kyoto, Japan
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, Kyoto, Japan
Sendai Headache and Neurology Clinic
Sendai, Miyagi, Japan
Tominaga Hospital
Osaka, Osaka, Japan
Saitama Neuropsychiatric Institute
Saitama-shi, Saitama, Japan
Tokyo Headache Clinic
Shibuya-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Nagamitsu Clinic
Hofu-shi, Yamaguchi, Japan
Nagaseki Headache Clinic
Kai-shi, Yamanashi, Japan
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, , Poland
Centrum Medyczne Luxmed Spzoo
Lublin, , Poland
Centrum Medyczne Hope Clinic Sebastian Szklener
Lublin, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
Poznan, , Poland
Dr Sekowska Leczenie Bolu
Warsaw, , Poland
Next Stage Spzoo
Warsaw, , Poland
Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, , Poland
Puerto Rico Health and Wellness Institute
Dorado, , Puerto Rico
FSBI Russian Children Clinical Hospital of the MoH RF
Moscow, , Russia
LLC clinic Chaika
Moscow, , Russia
LLC Sibneyromed
Novosibirsk, , Russia
LLC Medical Technologies
Saint Petersburg, , Russia
Noahs Ark Childrens Hospital for Wales
Cardiff, , United Kingdom
Royal Hospital for Children
Glasgow, , United Kingdom
4 Medical Clinical Solutions London
Ilford, , United Kingdom
Alder Hey Childrens Hospital
Liverpool, , United Kingdom
Evelina Childrens Hospital
London, , United Kingdom
Great Ormond Street Hospital for Children
London, , United Kingdom
4 Medical Clinical Solutions Manchester
Manchester, , United Kingdom
Oxford Childrens Hospital
Oxford, , United Kingdom
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-504928-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EMEA-001664-PIP02-15
Identifier Type: OTHER
Identifier Source: secondary_id
20160354
Identifier Type: -
Identifier Source: org_study_id
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