Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

457

Participants

Timeline

Start Date

July 19, 2019

Primary Completion Date

November 19, 2025

Study Completion Date

October 13, 2026

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 subjects 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.

Trial Locations (119)

1026

Dr Altmann Anna egyeni vallalkozo, Budapest

1027

High Tech Medical Kft, Budapest

1090

Universitair Ziekenhuis Brussel, Brussels

1094

Semmelweis Egyetem, Budapest

2660

Dr Kenessey Albert Korhaz - Rendelointezet, Balassagyarmat

2800

Algemeen Ziekenhuis Sint-Maarten, Mechelen

3526

Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Miskolc

4031

Universitaets-Kinderspital beider Basel, Basel

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4420

Docteur Simona Sava, Saint-Nicolas

8702

Kopfwehzentrum Hirslanden, Zollikon

10001

Modern Migraine MD, New York

10032

Columbia University Irving Medical Center, New York

13353

Charite - Universitaetsmedizin Berlin, Campus Virchow, Berlin

14226

New England Regional Headache Center Inc, Worcester

Dent Neurosciences Research Center, Amherst

15236

Preferred Primary Care Physicians, Inc, Pittsburgh

17475

Universitaetsklinikum Greifswald, Greifswald

19104

Childrens Hospital of Philadelphia, Philadelphia

20010

Childrens National Health System, Washington D.C.

20100

Terveystalo Pulssi, Turku

20133

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan

21201

University of Maryland, Baltimore, Baltimore

23507

Childrens Specialty Group, Norfolk

24149

Schmerzklinik Kiel, Kiel

25827

Vaught Neurological Services, Crab Orchard

27100

Fondazione Istituto Neurologico Nazionale C Mondino IRCCS, Pavia

29486

Palmetto Gastroenterology Clinical Research, LLC, Summerville

30329

Rare Disease Research Center Pediatrics, Atlanta

31008

Clinica Universidad de Navarra, Pamplona

31405

CenExel iResearch, LLC, Savannah

32561

Northwest Florida Clinical Research Group Limited Liability Company, Gulf Breeze

33155

Nicklaus Childrens Hospital, Miami

33407

Premiere Research Institute, West Palm Beach

33609

Pediatric Epilepsy and Neurology Specialists, Tampa

33612

TrueBlue Clinical Research, Tampa

41013

Hospital Universitario Virgen del Rocio, Seville

43205

Nationwide Childrens Hospital, Columbus

44195

Cleveland Clinic Foundation, Cleveland

45147

Universitaetsklinikum Essen, Essen

45229

Cincinnati Childrens Hospital Medical Center, Cincinnati

46026

Hospital Universitari i Politecnic La Fe, Valencia

46256

Josephson Wallack Munshower Neurology, Indianapolis

48104

Michigan Head Pain and Neurological Institute, Ann Arbor

50021

Servicios de Salud Ips Suramericana Sas - Ips Sura Industriales, Medellín

54449

Marshfield Clinic, Marshfield

55402

Clinical Research Institute Inc, Minneapolis

60611

Northwestern University, Chicago

60657

Chicago Headache Center and Research Institute, Chicago

63141

Mercy Research, St Louis

64108

Childrens Mercy Hospital and Clinics, Kansas City

68803

Velocity Clinical Research, Inc, Grand Island

75033

Stryde Consulting LLC, Frisco

76028

Helios Clinical Research Inc, Burleson

78757

Child Neurology Consultants of Austin, Austin

80045

Childrens Hospital Colorado, Aurora

80907

Colorado Springs Neurological Associates, Colorado Springs

90134

Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli, Palermo

92108

Paradigm Clinical Research Center Inc, San Diego

97239

Oregon Health and Science University, Portland

110221

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

111211

Cafam, Bogota

111221

Fundacion Hospital Infantil Universitario De San Jose, Bogota

119571

FSBI Russian Children Clinical Hospital of the MoH RF, Moscow

125047

LLC clinic Chaika, Moscow

191025

LLC Medical Technologies, Saint Petersburg

630004

LLC Sibneyromed, Novosibirsk

681017

Fundacion cardiovascular de Colombia, Bucaramanga

06905

New England Institute for Clinical Research, Stamford

T6G 1C9

Stollery Childrens Hospital, Edmonton

N6A 4G5

London Health Sciences Centre, London

K1H 8L1

Childrens Hospital of Eastern Ontario, Ottawa

M5G 1X8

The Hospital For Sick Children, Toronto

050021

Fundacion Centro de Investigacion Clinica, Medellín

054040

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

04107

Arzneimittelforschung Leipzig GmbH, Leipzig

00165

IRCCS Ospedale Pediatrico Bambino Gesu, Roma

451-0031

Josai Kids Clinic, Nagoya

790-0925

Medical Corporation Seikokai Takanoko Hospital, Matsuyama

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

060-0004

Kitami Clinic, Sapporo

658-0064

Konan Medical Center, Kobe

780-8011

Umenotsuji Clinic, Kochi

862-8505

Kumamoto City Hospital, Kumamoto

600-8811

Tatsuoka Neurology Clinic, Kyoto

605-0981

Japanese Red Cross Kyoto Daiichi Hospital, Kyoto

606-0851

Ishikawa Clinic, Kyoto

982-0014

Sendai Headache and Neurology Clinic, Sendai

556-0017

Tominaga Hospital, Osaka

338-8577

Saitama Neuropsychiatric Institute, Saitama-shi

160-0023

Tokyo Medical University Hospital, Shinjuku-ku

160-8582

Keio University Hospital, Shinjuku-ku

747-0802

Nagamitsu Clinic, Hofu-shi

400-0124

Nagaseki Headache Clinic, Kai-shi

15-274

Uniwersytecki Dzieciecy Szpital Kliniczny im Ludwika Zamenhofa w Bialymstoku, Bialystok

85-752

AthleticoMed, Bydgoszcz

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

93-338

Instytut Centrum Zdrowia Matki Polki, Lodz

20-109

Centrum Medyczne Luxmed Spzoo, Lublin

20-701

Centrum Medyczne Hope Clinic Sebastian Szklener, Lublin

60-355

Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan

61-731

Clinical Research Center Spzoo Medic-R Spolka Komandytowa, Poznan

01-018

Dr Sekowska Leczenie Bolu, Warsaw

02-121

Next Stage Spzoo, Warsaw

52-210

Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak, Wroclaw

3000-602

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

1169-045

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

1500-650

Hospital da Luz, SA, Lisbon

1649-035

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

00646

Puerto Rico Health and Wellness Institute, Dorado

08035

Hospital Universitari Vall d Hebron, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

CF14 4XW

Noahs Ark Childrens Hospital for Wales, Cardiff

G51 4TF

Royal Hospital for Children, Glasgow

L12 2AP

Alder Hey Childrens Hospital, Liverpool

SE1 7EU

Evelina Childrens Hospital, London

WC1N 3JH

Great Ormond Street Hospital for Children, London

M27 8FF

4 Medical Clinical Solutions Manchester, Manchester

OX3 9DU

Oxford Childrens Hospital, Oxford

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Amgen

INDUSTRY