- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03836040
Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine (OASIS(EM))
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 Episodic Migraine (OASIS PEDIATRIC [EM])
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine.
The trial consists of four phases: screening (up to 3 weeks of initial screening and a 4-week prospective baseline phase); the DBTP (24 weeks for Group 1 participants; 12-weeks for Group 2 participants) in which participants receive placebo or Erenumab dose 1, dose 2 or dose 3 (based on participant's body weight) via subcutaneous injection once a month; the optional dose level blinded extension phase (40 weeks), in which all participants are assigned to receive dose 1, dose 2 or dose 3 of Erenumab; and a 12 weeks safety follow-up phase (16 weeks after the last dose of investigational drug).
The study intends to enroll 456 participants (376 adolescents and up to 80 children).
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Amgen Call Center
- Phone Number: 866-572-6436
- Email: medinfo@amgen.com
Study Locations
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Brussel, Belgium, 1090
- Recruiting
- Universitair Ziekenhuis Brussel
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Mechelen, Belgium, 2800
- Recruiting
- Algemeen Ziekenhuis Sint-Maarten
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Saint Nicolas, Belgium, 4420
- Recruiting
- Docteur Simona Sava srl
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Alberta
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Edmonton, Alberta, Canada, T6G 1C9
- Recruiting
- Stollery Childrens Hospital
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Ontario
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London, Ontario, Canada, N6A 4G5
- Recruiting
- London Health Sciences Centre
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Ottawa, Ontario, Canada, K1H 8L1
- Recruiting
- Childrens Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Recruiting
- The Hospital For Sick Children
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Antioquia
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Medellín, Antioquia, Colombia, 050021
- Completed
- Fundacion Centro de Investigacion Clinica
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Cundinamarca
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Bogota, Cundinamarca, Colombia, 111211
- Terminated
- Cafam
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Bogota, Cundinamarca, Colombia, 111221
- Recruiting
- Fundacion Hospital Infantil Universitario De San Jose
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Bogota, Cundinamarca, Colombia, 110221
- Recruiting
- Solano y Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia Uniendo
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Santander
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Bucaramanga, Santander, Colombia, 681017
- Recruiting
- Fundacion Cardiovascular de Colombia
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Turku, Finland, 20100
- Completed
- Terveystalo Pulssi
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Berlin, Germany, 13353
- Recruiting
- Charite - Universitaetsmedizin Berlin, Campus Virchow
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Essen, Germany, 45147
- Recruiting
- Universitaetsklinikum Essen
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Kiel, Germany, 24149
- Recruiting
- Schmerzklinik Kiel
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Leipzig, Germany, 04107
- Completed
- Arzneimittelforschung Leipzig GmbH
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Balassagyarmat, Hungary, 2660
- Terminated
- Dr Kenessey Albert Korhaz - Rendelointezet
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Budapest, Hungary, 1083
- Recruiting
- Semmelweis Egyetem
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Budapest, Hungary, 1026
- Terminated
- Dr Altmann Anna egyeni vallalkozo
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Budapest, Hungary, 1027
- Recruiting
- High Tech Medical Kft
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Debrecen, Hungary, 4032
- Recruiting
- Debreceni Egyetem Klinikai Kozpont
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Miskolc, Hungary, 3526
- Terminated
- Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
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Milano, Italy, 20133
- Completed
- Fondazione IRCCS Istituto Neurologico Carlo Besta
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Palermo, Italy, 90134
- Recruiting
- Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
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Pavia, Italy, 27100
- Recruiting
- Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
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Roma, Italy, 00165
- Recruiting
- IRCCS Ospedale Pediatrico Bambino Gesu
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Aichi
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Nagoya-shi, Aichi, Japan, 451-0031
- Recruiting
- Josai Kids Clinic
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Hiroshima
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Hiroshima-shi, Hiroshima, Japan, 730-8518
- Terminated
- Hiroshima City Hiroshima Citizens Hospital
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Hokkaido
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Sapporo-shi, Hokkaido, Japan, 060-0004
- Terminated
- Kitami Clinic
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Hyogo
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Kobe-shi, Hyogo, Japan, 658-0064
- Recruiting
- Konan Medical Center
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Kumamoto
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Kumamoto-shi, Kumamoto, Japan, 862-8505
- Recruiting
- Kumamoto City Hospital
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Kyoto
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Kyoto-shi, Kyoto, Japan, 600-8811
- Recruiting
- Tatsuoka Neurology Clinic
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Kyoto-shi, Kyoto, Japan, 606-0851
- Recruiting
- Ishikawa Clinic
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Kyoto-shi, Kyoto, Japan, 605-0981
- Recruiting
- Japanese Red Cross Kyoto Daiichi Hospital
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Miyagi
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Sendai-shi, Miyagi, Japan, 982-0014
- Recruiting
- Sendai Headache and Neurology Clinic
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Osaka
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Osaka-shi, Osaka, Japan, 556-0017
- Recruiting
- Tominaga Hospital
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Saitama
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Saitama-shi, Saitama, Japan, 338-8577
- Recruiting
- Saitama Neuropsychiatric Institute
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 160-8582
- Recruiting
- Keio University Hospital
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Shinjuku-ku, Tokyo, Japan, 160-0023
- Recruiting
- Tokyo Medical University Hospital
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Yamaguchi
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Hofu-shi, Yamaguchi, Japan, 747-0802
- Recruiting
- Nagamitsu Clinic
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Yamanashi
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Kai-shi, Yamanashi, Japan, 400-0124
- Recruiting
- Nagaseki Headache Clinic
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Bialystok, Poland, 15-274
- Terminated
- Uniwersytecki Dzieciecy Szpital Kliniczny im Ludwika Zamenhofa w Bialymstoku
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Bydgoszcz, Poland, 85-752
- Recruiting
- AthleticoMed
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Gdansk, Poland, 80-952
- Recruiting
- Uniwersyteckie Centrum Kliniczne
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Lodz, Poland, 93-338
- Completed
- Instytut Centrum Zdrowia Matki Polki
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Lublin, Poland, 20-109
- Completed
- Centrum Medyczne Luxmed Spzoo
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Lublin, Poland, 20-701
- Recruiting
- Centrum Medyczne Hope Clinic Sebastian Szklener
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Poznan, Poland, 61-731
- Recruiting
- Clinical Research Center Spzoo Medic-R Spolka Komandytowa
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Poznan, Poland, 60-355
- Recruiting
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Warszawa, Poland, 01-018
- Recruiting
- Dr Sekowska Leczenie Bolu
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Warszawa, Poland, 02-121
- Recruiting
- Next Stage Spzoo
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Wroclaw, Poland, 52-210
- Recruiting
- Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
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Coimbra, Portugal, 3000-602
- Recruiting
- Centro Hospitalar e Universitario de Coimbra, EPE - Hospital Pediatrico de Coimbra
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Lisboa, Portugal, 1649-035
- Recruiting
- Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
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Lisboa, Portugal, 1500-650
- Recruiting
- Hospital da Luz, SA
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Lisboa, Portugal, 1169-045
- Recruiting
- Centro Hospitalar Universitario de Lisboa Central, EPE - Hospital Dona Estefania
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Dorado, Puerto Rico, 00646
- Recruiting
- Puerto Rico Health and Wellness Institute
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Moscow, Russian Federation, 125047
- Recruiting
- LLC clinic Chaika
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Moscow, Russian Federation, 119571
- Terminated
- FSBI Russian Children Clinical Hospital of the MoH RF
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Novosibirsk, Russian Federation, 630004
- Recruiting
- LLC Sibneyromed
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Saint Petersburg, Russian Federation, 191025
- Terminated
- LLC Medical Technologies
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Andalucía
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Sevilla, Andalucía, Spain, 41013
- Recruiting
- Hospital Universitario Virgen Del Rocio
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Cataluña
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Barcelona, Cataluña, Spain, 08041
- Recruiting
- Hospital de la Santa Creu i Sant Pau
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Barcelona, Cataluña, Spain, 08035
- Recruiting
- Hospital Universitari Vall d Hebron
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, Spain, 46026
- Recruiting
- Hospital Universitari i Politecnic La Fe
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Navarra
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Pamplona, Navarra, Spain, 31008
- Recruiting
- Clinica Universidad de Navarra
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Basel, Switzerland, 4031
- Terminated
- Universitaets-Kinderspital beider Basel
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Zollikon, Switzerland, 8702
- Completed
- Kopfwehzentrum Hirslanden
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Cardiff, United Kingdom, CF14 4XW
- Terminated
- Noahs Ark Childrens Hospital for Wales
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Glasgow, United Kingdom, G51 4TF
- Recruiting
- Royal Hospital for Children
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Liverpool, United Kingdom, L12 2AP
- Terminated
- Alder Hey Childrens Hospital
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London, United Kingdom, WC1N 3JH
- Recruiting
- Great Ormond Street Hospital for Children
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London, United Kingdom, SE1 7EU
- Recruiting
- Evelina Childrens Hospital
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Oxford, United Kingdom, OX3 9DU
- Completed
- Oxford Childrens Hospital
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California
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San Diego, California, United States, 92108
- Recruiting
- Paradigm Clinical Research Center Inc
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- Childrens Hospital Colorado
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Colorado Springs, Colorado, United States, 80907
- Completed
- Colorado Springs Neurological Associates
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Connecticut
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Stamford, Connecticut, United States, 06905
- Recruiting
- New England Institute for Clinical Research
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Recruiting
- Childrens National Health System
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Florida
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Brandon, Florida, United States, 33511
- Recruiting
- TrueBlue Clinical Research
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Gulf Breeze, Florida, United States, 32561
- Recruiting
- Northwest Florida Clinical Research Group Limited Liability Company
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Miami, Florida, United States, 33155
- Completed
- Nicklaus Childrens Hospital
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Miami, Florida, United States, 33155
- Recruiting
- Nicklaus Childrens Hospital
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West Palm Beach, Florida, United States, 33407
- Completed
- Premiere Research Institute
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Georgia
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Atlanta, Georgia, United States, 30329
- Recruiting
- Rare Disease Research Center Pediatrics
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Savannah, Georgia, United States, 31405
- Recruiting
- CenExel iResearch, LLC
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Illinois
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Chicago, Illinois, United States, 60611
- Recruiting
- Ann and Robert H Lurie Childrens Hospital of Chicago
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Chicago, Illinois, United States, 60657
- Recruiting
- Chicago Headache Center and Research Institute
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Indiana
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Indianapolis, Indiana, United States, 46256
- Recruiting
- Josephson Wallack Munshower Neurology
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Maryland
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Baltimore, Maryland, United States, 21201
- Terminated
- University of Maryland, Baltimore
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Massachusetts
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Worcester, Massachusetts, United States, 14226
- Terminated
- New England Regional Headache Center Inc
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-
Michigan
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Ann Arbor, Michigan, United States, 48104
- Recruiting
- Michigan Head Pain and Neurological Institute
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-
Minnesota
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Minneapolis, Minnesota, United States, 55402
- Terminated
- Clinical Research Institute Inc
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-
Missouri
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Kansas City, Missouri, United States, 64108
- Recruiting
- Childrens Mercy Hospital and Clinics
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Saint Louis, Missouri, United States, 63141
- Completed
- Mercy Research
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-
Nebraska
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Hastings, Nebraska, United States, 68901
- Recruiting
- Meridian Clinical Research LLC
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-
New York
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Amherst, New York, United States, 14226
- Terminated
- Dent Neurosciences Research Center
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New York, New York, United States, 10032
- Terminated
- Columbia University Medical Center
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New York, New York, United States, 10001
- Recruiting
- Modern Migraine MD
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Ohio
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Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Childrens Hospital Medical Center
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Cleveland, Ohio, United States, 44195
- Terminated
- Cleveland Clinic
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Columbus, Ohio, United States, 43205
- Recruiting
- Nationwide Childrens Hospital
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-
Oregon
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Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Childrens Hospital of Philadelphia
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Pittsburgh, Pennsylvania, United States, 15236
- Completed
- Preferred Primary Care Physicians, Inc
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South Carolina
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Summerville, South Carolina, United States, 29486
- Recruiting
- Palmetto Gastroenterology Clinical Research, LLC
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-
Texas
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Burleson, Texas, United States, 76028
- Recruiting
- Helios Clinical Research Inc
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Frisco, Texas, United States, 75033
- Recruiting
- Stryde Consulting LLC
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-
Virginia
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Norfolk, Virginia, United States, 23507
- Recruiting
- Childrens Specialty Group
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West Virginia
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Crab Orchard, West Virginia, United States, 25827
- Recruiting
- Vaught Neurological Services
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Terminated
- Marshfield Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
Other Names:
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.
Other Names:
|
Experimental: 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.
|
Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
Other Names:
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.
Other Names:
|
Placebo Comparator: Placebo
Participants will be randomized to a placebo comparator.
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Placebo matching dose for erenumab dose 1, 2 and 3.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in MMDs
Time Frame: Baseline through week 12 of the double blind treatment phase
|
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP).
|
Baseline through week 12 of the double blind treatment phase
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in monthly headache days from baseline
Time Frame: Baseline through week 12 of the double blind treatment phase
|
To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly headache days to week 9 through week 12 (month 3) of the DBTP
|
Baseline through week 12 of the double blind treatment phase
|
Proportion of participants with at least 50% reduction in MMDs from baseline
Time Frame: Baseline through week 12 of the double blind treatment phase
|
To evaluate the effect of erenumab compared with placebo on the proportion of participants with at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the DBTP
|
Baseline through week 12 of the double blind treatment phase
|
Change in MMDs from baseline to the average of the first 3 months
Time Frame: Baseline through week 12 of the double blind treatment phase
|
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the first 3 months (week 1 through week 12) of the DBTP
|
Baseline through week 12 of the double blind treatment phase
|
Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)
Time Frame: Baseline through week 12 of the double blind treatment phase
|
To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly average severity of migraine attacks to week 9 through week 12 (month 3) of the DBTP.
This will be measured in a daily electronic diary (eDiary) with a visual analogue scale.
|
Baseline through week 12 of the double blind treatment phase
|
Change from baseline in migraine-related disability and productivity
Time Frame: Baseline through week 12 of the double blind treatment phase
|
To evaluate the effect of erenumab compared with placebo on the change from baseline in migraine-related disability and productivity as measured by the modified PedMIDAS to week 9 through week 12 (month 3) of the DBTP.
|
Baseline through week 12 of the double blind treatment phase
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Immunologic Factors
- Calcitonin Gene-Related Peptide Receptor Antagonists
- Antibodies, Monoclonal
- Erenumab
Other Study ID Numbers
- 20150125
- 2023-504930-23 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Migraine
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Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
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Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
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Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
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University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
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CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
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University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
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Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
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Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
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The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
Clinical Trials on Placebo
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SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
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National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
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Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States