Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine
- Conditions
- Migraine
- Interventions
- Registration Number
- NCT03836040
- Lead Sponsor
- Amgen
- Brief 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 episodic migraine. The study hypothesis is that in pediatric participants with episodic 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).
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 456
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose level 1 Erenumab Dose 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. Dose level 1 Erenumab Dose 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. Dose level 2 Erenumab Dose 3 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. Dose level 2 Erenumab Dose 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. Placebo Placebo Participants will be randomized to a placebo comparator.
- Primary Outcome Measures
Name Time Method Change from baseline in MMDs 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).
- Secondary Outcome Measures
Name Time Method Proportion of participants with at least 50% reduction in MMDs from baseline 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
Change in monthly headache days from baseline 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
Change in MMDs from baseline to the average of the first 3 months 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
Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale) 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.
Change from baseline in migraine-related disability and productivity 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.
Trial Locations
- Locations (118)
Fundacion Centro de Investigacion Clinica
🇨🇴Medellín, Antioquia, Colombia
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, District of Columbia, 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
TrueBlue Clinical Research
🇺🇸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
🇺🇸Minneapolis, Minnesota, United States
Childrens Mercy Hospital and Clinics
🇺🇸Kansas City, Missouri, United States
Mercy Research
🇺🇸Saint Louis, Missouri, United States
Velocity Clinical Research, Inc
🇺🇸Grand Island, Nebraska, United States
Dent Neurosciences Research Center
🇺🇸Amherst, 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
Servicios de Salud Ips Suramericana Sas - Ips Sura Industriales
🇨🇴Medellin, Antioquia, Colombia
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
🇧🇪Brussel, 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
Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
🇨🇴Rionegro, Antioquia, Colombia
Solano y Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia Uniendo
🇨🇴Bogota, Cundinamarca, Colombia
Cafam
🇨🇴Bogota, Cundinamarca, Colombia
Fundacion Hospital Infantil Universitario De San Jose
🇨🇴Bogota, Cundinamarca, Colombia
Fundacion cardiovascular de Colombia
🇨🇴Bucaramanga, Santander, Colombia
Terveystalo Pulssi
🇫🇮Turku, Finland
Charite - Universitaetsmedizin Berlin, Campus Virchow
🇩🇪Berlin, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Universitaetsklinikum Greifswald
🇩🇪Greifswald, 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
🇮🇹Milano, 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-shi, Aichi, Japan
Medical Corporation Seikokai Takanoko Hospital
🇯🇵Matsuyama-shi, Ehime, Japan
Hiroshima City Hiroshima Citizens Hospital
🇯🇵Hiroshima-shi, Hiroshima, Japan
Kitami Clinic
🇯🇵Sapporo-shi, Hokkaido, Japan
Konan Medical Center
🇯🇵Kobe-shi, Hyogo, Japan
Umenotsuji Clinic
🇯🇵Kochi-shi, Kochi, Japan
Kumamoto City Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Tatsuoka Neurology Clinic
🇯🇵Kyoto-shi, Kyoto, Japan
Japanese Red Cross Kyoto Daiichi Hospital
🇯🇵Kyoto-shi, Kyoto, Japan
Ishikawa Clinic
🇯🇵Kyoto-shi, Kyoto, Japan
Sendai Headache and Neurology Clinic
🇯🇵Sendai-shi, Miyagi, Japan
Tominaga Hospital
🇯🇵Osaka-shi, Osaka, Japan
Saitama Neuropsychiatric Institute
🇯🇵Saitama-shi, Saitama, 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
Uniwersytecki Dzieciecy Szpital Kliniczny im Ludwika Zamenhofa w Bialymstoku
🇵🇱Bialystok, Poland
AthleticoMed
🇵🇱Bydgoszcz, Poland
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
🇵🇱Warszawa, Poland
Next Stage Spzoo
🇵🇱Warszawa, Poland
Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
🇵🇱Wroclaw, Poland
Unidade Local de Saude de Coimbra, EPE - Hospital Pediatrico de Coimbra
🇵🇹Coimbra, Portugal
Unidade Local de Saude de Sao Jose, EPE - Hospital Dona Estefania
🇵🇹Lisboa, Portugal
Hospital da Luz, SA
🇵🇹Lisboa, Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Puerto Rico Health and Wellness Institute
🇵🇷Dorado, Puerto Rico
FSBI Russian Children Clinical Hospital of the MoH RF
🇷🇺Moscow, Russian Federation
LLC clinic Chaika
🇷🇺Moscow, Russian Federation
LLC Sibneyromed
🇷🇺Novosibirsk, Russian Federation
LLC Medical Technologies
🇷🇺Saint Petersburg, Russian Federation
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Andalucía, Spain
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Cataluña, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Comunidad Valenciana, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Universitaets-Kinderspital beider Basel
🇨🇭Basel, Switzerland
Kopfwehzentrum Hirslanden
🇨🇭Zollikon, Switzerland
Noahs Ark Childrens Hospital for Wales
🇬🇧Cardiff, United Kingdom
Royal Hospital for Children
🇬🇧Glasgow, 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