Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
OASIS(CM)
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])
3 other identifiers
interventional
284
13 countries
101
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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2019
Longer than P75 for phase_3
101 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2019
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedStudy Start
First participant enrolled
September 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2026
CompletedJanuary 20, 2026
January 1, 2026
5.3 years
January 29, 2019
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in MMDs
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 DBTP.
Baseline through week 12 of DBTP
Secondary Outcomes (13)
Change in monthly headache days from baseline
Baseline through week 12 of the DBTP
Proportion of participants with at least 50% reduction in MMDs from baseline
Baseline through week 12 of the DBTP
Change in MMDs from baseline to the average of the first 3 months
Baseline 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
Change from baseline in migraine-related disability and productivity as assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)
Baseline through week 12 of the DBTP
- +8 more secondary outcomes
Study Arms (3)
Dose Level 1
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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 COMPARATORInterventions
Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
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.
Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (101)
Paradigm Clinical Research Center Inc
San Diego, California, 92108, United States
Childrens Hospital Colorado
Aurora, Colorado, 80045, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
Childrens National Health System
Washington D.C., District of Columbia, 20010, United States
TrueBlue Clinical Research
Brandon, Florida, 33511, United States
Northwest Florida Clinical Research Group Limited Liability Company
Gulf Breeze, Florida, 32561, United States
Nicklaus Childrens Hospital
Miami, Florida, 33155, United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, 33609, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Rare Disease Research Center Pediatrics
Atlanta, Georgia, 30329, United States
CenExel iResearch, LLC
Savannah, Georgia, 31405, United States
Northwestern University
Chicago, Illinois, 60611, United States
Chicago Headache Center and Research Institute
Chicago, Illinois, 60657, United States
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, 46256, United States
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
New England Regional Headache Center Inc
Worcester, Massachusetts, 14226, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinical Research Institute Inc
Plymouth, Minnesota, 55441, United States
Childrens Mercy Hospital and Clinics
Kansas City, Missouri, 64108, United States
Mercy Research
St Louis, Missouri, 63141, United States
Meridian Clinical Research LLC
Hastings, Nebraska, 68901, United States
Dent Neurosciences Research Center
Amherst, New York, 14226, United States
Modern Migraine MD
New York, New York, 10001, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Childrens Hospital
Columbus, Ohio, 43205, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, 15236, United States
Palmetto Gastroenterology Clinical Research, LLC
Summerville, South Carolina, 29486, United States
Child Neurology Consultants of Austin
Austin, Texas, 78757, United States
Helios Clinical Research Inc
Burleson, Texas, 76028, United States
Stryde Consulting LLC
Frisco, Texas, 75033, United States
Childrens Specialty Group
Norfolk, Virginia, 23507, United States
Vaught Neurological Services
Crab Orchard, West Virginia, 25827, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Algemeen Ziekenhuis Sint-Maarten
Mechelen, 2800, Belgium
Docteur Simona Sava
Saint-Nicolas, 4420, Belgium
Stollery Childrens Hospital
Edmonton, Alberta, T6G 1C9, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
The Hospital For Sick Children
Toronto, Ontario, M5G 1X8, Canada
Fundacion Centro de Investigacion Clinica
Medellín, Antioquia, 050021, Colombia
Cafam
Bogota, Cundinamarca, 111211, Colombia
Fundacion Cardiovascular de Colombia
Bucaramanga, Santander Department, 681017, Colombia
Terveystalo Pulssi
Turku, 20100, Finland
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin, 13353, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Schmerzklinik Kiel
Kiel, 24149, Germany
Arzneimittelforschung Leipzig GmbH
Leipzig, 04107, Germany
Dr Kenessey Albert Korhaz - Rendelointezet
Balassagyarmat, 2660, Hungary
Dr Altmann Anna egyeni vallalkozo
Budapest, 1026, Hungary
High Tech Medical Kft
Budapest, 1027, Hungary
Semmelweis Egyetem
Budapest, 1094, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3526, Hungary
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133, Italy
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, 90134, Italy
Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
Pavia, 27100, Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165, Italy
Josai Kids Clinic
Nagoya, Aichi-ken, 451-0031, Japan
Medical Corporation Seikokai Takanoko Hospital
Matsuyama, Ehime, 790-0925, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, 730-8518, Japan
Kitami Clinic
Sapporo, Hokkaido, 060-0004, Japan
Konan Medical Center
Kobe, Hyōgo, 658-0064, Japan
Kumamoto City Hospital
Kumamoto, Kumamoto, 862-8505, Japan
Tatsuoka Neurology Clinic
Kyoto, Kyoto, 600-8811, Japan
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, Kyoto, 605-0981, Japan
Sendai Headache and Neurology Clinic
Sendai, Miyagi, 982-0014, Japan
Tominaga Hospital
Osaka, Osaka, 556-0017, Japan
Saitama Neuropsychiatric Institute
Saitama-shi, Saitama, 338-8577, Japan
Tokyo Headache Clinic
Shibuya-ku, Tokyo, 151-0051, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Nagamitsu Clinic
Hofu-shi, Yamaguchi, 747-0802, Japan
Nagaseki Headache Clinic
Kai-shi, Yamanashi, 400-0124, Japan
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338, Poland
Centrum Medyczne Luxmed Spzoo
Lublin, 20-109, Poland
Centrum Medyczne Hope Clinic Sebastian Szklener
Lublin, 20-701, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-355, Poland
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
Poznan, 61-731, Poland
Dr Sekowska Leczenie Bolu
Warsaw, 01-018, Poland
Next Stage Spzoo
Warsaw, 02-121, Poland
Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, 52-210, Poland
Puerto Rico Health and Wellness Institute
Dorado, 00646, Puerto Rico
FSBI Russian Children Clinical Hospital of the MoH RF
Moscow, 119571, Russia
LLC clinic Chaika
Moscow, 125047, Russia
LLC Sibneyromed
Novosibirsk, 630004, Russia
LLC Medical Technologies
Saint Petersburg, 191025, Russia
Noahs Ark Childrens Hospital for Wales
Cardiff, CF14 4XW, United Kingdom
Royal Hospital for Children
Glasgow, G51 4TF, United Kingdom
4 Medical Clinical Solutions London
Ilford, IG1 4HP, United Kingdom
Alder Hey Childrens Hospital
Liverpool, L12 2AP, United Kingdom
Evelina Childrens Hospital
London, SE1 7EU, United Kingdom
Great Ormond Street Hospital for Children
London, WC1N 3JH, United Kingdom
4 Medical Clinical Solutions Manchester
Manchester, M27 8FF, United Kingdom
Oxford Childrens Hospital
Oxford, OX3 9DU, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2019
First Posted
February 6, 2019
Study Start
September 5, 2019
Primary Completion
January 8, 2025
Study Completion
January 7, 2026
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.