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NCT03832998

PHASE3

Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to \<12 years) and adolescents (12 to \<18 years) with chronic migraine. The study hypothesis is that in pediatric participants with chronic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Chronic Migraine (OASIS PEDIATRIC [CM])

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

284

Start Date

2019-09-05

Completion Date

2026-01-07

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Migraine

Interventions

DRUG

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.

DRUG

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.

DRUG

Erenumab Dose 3

Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.

OTHER

Placebo

Placebo matching dose for erenumab dose 1, 2 and 3.

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.

Locations (101)

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

And 1 more locations on ClinicalTrials.gov

Clinical Research Directory

Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (101)