MigrainePhase 3OASIS(CM)NCT03832998
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
A Phase 3 study testing Erenumab Dose 1, Erenumab Dose 2 and Erenumab Dose 3 in people with Migraine, run by Amgen at 101 sites in 13 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine
- What is being tested?
- Erenumab Dose 1, Erenumab Dose 2 and Erenumab Dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 101 sitesin 13 countries
- Study dates
- 5 Sep 2019to 7 Jan 2026
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
101 sites in 13 countries.
101 sites in 13 countries
United States38 sites
Dent Neurosciences Research Center
Amherst, New York, 14226
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104
Rare Disease Research Center Pediatrics
Atlanta, Georgia, 30329
Childrens Hospital Colorado
Aurora, Colorado, 80045
Child Neurology Consultants of Austin
Austin, Texas, 78757
University of Maryland, Baltimore
Baltimore, Maryland, 21201
TrueBlue Clinical Research
Brandon, Florida, 33511
Helios Clinical Research Inc
Burleson, Texas, 76028
Northwestern University
Chicago, Illinois, 60611
Chicago Headache Center and Research Institute
Chicago, Illinois, 60657
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
Nationwide Childrens Hospital
Columbus, Ohio, 43205
Vaught Neurological Services
Crab Orchard, West Virginia, 25827
Stryde Consulting LLC
Frisco, Texas, 75033
Northwest Florida Clinical Research Group Limited Liability Company
Gulf Breeze, Florida, 32561
Meridian Clinical Research LLC
Hastings, Nebraska, 68901
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, 46256
Childrens Mercy Hospital and Clinics
Kansas City, Missouri, 64108
Marshfield Clinic
Marshfield, Wisconsin, 54449
Nicklaus Childrens Hospital
Miami, Florida, 33155
Modern Migraine MD
New York, New York, 10001
Columbia University Irving Medical Center
New York, New York, 10032
Childrens Specialty Group
Norfolk, Virginia, 23507
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, 15236
Clinical Research Institute Inc
Plymouth, Minnesota, 55441
Oregon Health and Science University
Portland, Oregon, 97239
Paradigm Clinical Research Center Inc
San Diego, California, 92108
CenExel iResearch, LLC
Savannah, Georgia, 31405
Mercy Research
St Louis, Missouri, 63141
New England Institute for Clinical Research
Stamford, Connecticut, 06905
Palmetto Gastroenterology Clinical Research, LLC
Summerville, South Carolina, 29486
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, 33609
Childrens National Health System
Washington D.C., District of Columbia, 20010
Premiere Research Institute
West Palm Beach, Florida, 33407
New England Regional Headache Center Inc
Worcester, Massachusetts, 14226
Japan16 sites
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, 730-8518
Nagamitsu Clinic
Hofu-shi, Yamaguchi, 747-0802
Nagaseki Headache Clinic
Kai-shi, Yamanashi, 400-0124
Konan Medical Center
Kobe, Hyōgo, 658-0064
Kumamoto City Hospital
Kumamoto, Kumamoto, 862-8505
Tatsuoka Neurology Clinic
Kyoto, Kyoto, 600-8811
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, Kyoto, 605-0981
Medical Corporation Seikokai Takanoko Hospital
Matsuyama, Ehime, 790-0925
Josai Kids Clinic
Nagoya, Aichi-ken, 451-0031
Tominaga Hospital
Osaka, Osaka, 556-0017
Saitama Neuropsychiatric Institute
Saitama-shi, Saitama, 338-8577
Kitami Clinic
Sapporo, Hokkaido, 060-0004
Sendai Headache and Neurology Clinic
Sendai, Miyagi, 982-0014
Tokyo Headache Clinic
Shibuya-ku, Tokyo, 151-0051
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Poland9 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338
Centrum Medyczne Luxmed Spzoo
Lublin, 20-109
Centrum Medyczne Hope Clinic Sebastian Szklener
Lublin, 20-701
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-355
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
Poznan, 61-731
Dr Sekowska Leczenie Bolu
Warsaw, 01-018
Next Stage Spzoo
Warsaw, 02-121
Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, 52-210
United Kingdom8 sites
Noahs Ark Childrens Hospital for Wales
Cardiff, CF14 4XW
Royal Hospital for Children
Glasgow, G51 4TF
4 Medical Clinical Solutions London
Ilford, IG1 4HP
Alder Hey Childrens Hospital
Liverpool, L12 2AP
Evelina Childrens Hospital
London, SE1 7EU
Great Ormond Street Hospital for Children
London, WC1N 3JH
4 Medical Clinical Solutions Manchester
Manchester, M27 8FF
Oxford Childrens Hospital
Oxford, OX3 9DU
Hungary6 sites
Dr Kenessey Albert Korhaz - Rendelointezet
Balassagyarmat, 2660
Dr Altmann Anna egyeni vallalkozo
Budapest, 1026
High Tech Medical Kft
Budapest, 1027
Semmelweis Egyetem
Budapest, 1094
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3526
Canada4 sites
Stollery Childrens Hospital
Edmonton, Alberta, T6G 1C9
London Health Sciences Centre
London, Ontario, N6A 4G5
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Hospital For Sick Children
Toronto, Ontario, M5G 1X8
Germany4 sites
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin, 13353
Universitaetsklinikum Essen
Essen, 45147
Schmerzklinik Kiel
Kiel, 24149
Arzneimittelforschung Leipzig GmbH
Leipzig, 04107
Italy4 sites
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, 90134
Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
Pavia, 27100
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165
Russia4 sites
FSBI Russian Children Clinical Hospital of the MoH RF
Moscow, 119571
LLC clinic Chaika
Moscow, 125047
LLC Sibneyromed
Novosibirsk, 630004
LLC Medical Technologies
Saint Petersburg, 191025
Belgium3 sites
Universitair Ziekenhuis Brussel
Brussels, 1090
Algemeen Ziekenhuis Sint-Maarten
Mechelen, 2800
Docteur Simona Sava
Saint-Nicolas, 4420
Colombia3 sites
Cafam
Bogota, Cundinamarca, 111211
Fundacion Cardiovascular de Colombia
Bucaramanga, Santander Department, 681017
Fundacion Centro de Investigacion Clinica
Medellín, Antioquia, 050021
About this study
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])
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).
Read the 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 chronic 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 subjects; 12-weeks for Group 2 subjects) 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 enrol 286 participants (256 adolescents and 30 children).
- Conditions
- Migraine
- Being tested
- Erenumab Dose 1, Erenumab Dose 2, Erenumab Dose 3, Placebo
- Keywords
- Migraine, Headache, Prevention, Pediatric, Chronic Migraine
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erenumab Dose 1Drug
Also called AMG 334, Aimovig®
Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
Erenumab Dose 2Drug
Also called AMG 334, Aimovig®
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.
Erenumab Dose 3Drug
Also called AMG 334, Aimovig®
Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
PlaceboOther
Placebo matching dose for erenumab dose 1, 2 and 3.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | 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. Receives: Drug: Erenumab Dose 1; Drug: Erenumab Dose 2 |
| Dose Level 2 | Experimental | 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. Receives: Drug: Erenumab Dose 2; Drug: Erenumab Dose 3 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in MMD to Week 9 Through Week 12 (Month 3) of the DBTP
A migraine day was defined as any calendar day in which the participant developed a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). MMD was defined as the number of migraine days between each monthly IP dose. MMD at baseline was the number of migraine days in the 4-week baseline phase.
The least squares mean (LSM) was calculated using a linear mixed effects repeated measures model including treatment group, baseline value as covariate, stratification factors of region and prior preventive treatment failure, scheduled visit, and interaction of treatment group with scheduled visit. Participants were used as a random effect.
As pre-specified in the Statistical Analysis Plan (SAP), only results from adolescents are presented.
Measured: Baseline to Week 12
Secondary outcomes (5)
Change From Baseline in Monthly Headache Days to Week 9 Through Week 12 (Month 3) of the DBTP
A headache day was defined as any calendar day in which the participant develops a qualified headache (onset, continuation, or recurrence of the headache). Monthly headache days were defined as the number of headache days between each monthly IP dose. Monthly headache days at baseline was the number of headache days in the 4-week baseline phase.
LSM was calculated using a linear mixed effects repeated measures model including treatment group, baseline value as covariate, stratification factors of region and prior preventive treatment failure, scheduled visit, and interaction of treatment with scheduled visit. Participants were used as a random effect.
As pre-specified in the SAP, only results from adolescents are presented.
Measured: Baseline to Week 12
Number of Participants With at Least 50% Reduction in MMD From Baseline to Week 9 Through Week 12 (Month 3) of the DBTP
A migraine day was defined as any calendar day in which the participant developed a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). MMD was defined as the number of migraine days between each monthly IP dose. MMD at baseline was the number of migraine days in the 4-week baseline phase. All participants included in the overall number of participants analyzed contributed to the post-baseline data for this endpoint.
As pre-specified in the SAP, only results from adolescents are presented.
Measured: Baseline to Week 12
Change From Baseline in MMD to the Average of the First 3 Months (Week 1 Through Week 12) of the DBTP
A migraine day was defined as any calendar day in which the participant developed a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). MMD was defined as the number of migraine days between each monthly IP dose. MMD at baseline was the number of migraine days in the 4-week baseline phase.
LSM was calculated using a fixed effects analysis of covariance (ANCOVA) model, including terms for treatment group, baseline value as covariate, and stratification factors of region and prior preventive treatment failure.
As pre-specified in the SAP, only results from adolescents are presented.
Measured: Baseline to Week 12
Change From Baseline in Monthly Average Severity of Migraine Attacks to Week 9 Through Week 12 (Month 3) of the DBTP
Severity of qualified migraine headache was measured by using 100 mm Visual Analogue Scale (VAS). Monthly average severity of migraine attack was defined as sum of the severity of each migraine episodes during the migraine attacks between two consecutive monthly IP doses divided by total number of observed migraine episodes during migraine attacks in that monthly interval. 100 mm VAS ranged from 0 to 100 mm, where 0 represents no pain (lowest severity of migraine) and 100 represents worst possible pain (highest severity of migraine). Negative change from baseline indicates an improvement in symptoms.
LSM was calculated using a linear mixed effects repeated measures model including treatment group, baseline value as covariate, stratification factors of region and prior preventive treatment failure, scheduled visit, and interaction of treatment with scheduled visit. Participants were used as a random effect.
As pre-specified in the SAP, only results from adolescents are presented.
Measured: Baseline to Week 12
Change From Baseline in Migraine-related Disability and Productivity as Measured by the Modified Pediatric Migraine Disability Assessment (PedMIDAS) to Week 9 Through Week 12 (Month 3) of the DBTP
Modified PedMIDAS is a 6-item self-administered questionnaire that measures the disability in 2 settings: at school and at home. Modified PedMIDAS score is the sum of missed school days, days when activities at school or home were reduced by at least half due to headaches, and days when other family, social, leisure activities were reduced by at least half due to headaches. Modified PedMIDAS: 0-10: little/none;11-30: mild; 31-50: moderate; >50; severe; Minimum value 0, maximum value 80, higher scores mean a worse outcome. Negative change from baseline indicates an improvement in symptoms.
LSM was calculated using a linear mixed effects repeated measures model including treatment group, baseline value as covariate, stratification factors of region and prior preventive treatment failure, scheduled visit, and interaction of treatment with scheduled visit. Participants were used as a random effect.
As pre-specified in the SAP, only results from adolescents are presented.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start5 Sep 2019
- Primary completion8 Jan 2025
- Study completion7 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832998
- Sponsor's protocol ID
- 20160354
- Other IDs
- 2023-504928-26, EMEA-001664-PIP02-15, 2023-504928-26-00, 2023
- Acronym
- OASIS(CM)
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2019
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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])
- ClinicalTrials.gov ID
- NCT03832998
- Acronym / sponsor ID
- OASIS(CM) / 20160354
- Conditions
- Migraine
- Keywords
- Migraine, Headache, Prevention, Pediatric, Chronic Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 chronic 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 subjects; 12-weeks for Group 2 subjects) 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 enrol 286 participants (256 adolescents and 30 children).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: Erenumab Dose 1, Drug: Erenumab Dose 2Participants 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 | Experimental | Drug: Erenumab Dose 2, Drug: Erenumab Dose 3Participants 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 comparator | Other: Placebo |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erenumab Dose 1Also: AMG 334, Aimovig®Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose. | Drug | Dose Level 1 |
| Erenumab Dose 2Also: AMG 334, Aimovig®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 | Dose Level 1, Dose Level 2 |
| Erenumab Dose 3Also: AMG 334, Aimovig®Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose. | Drug | Dose Level 2 |
| PlaceboPlacebo matching dose for erenumab dose 1, 2 and 3. | Other | Placebo |
Primary outcome
Change From Baseline in MMD to Week 9 Through Week 12 (Month 3) of the DBTP
Time frame: Baseline to Week 12
A migraine day was defined as any calendar day in which the participant developed a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). MMD was defined as the number of migraine days between each monthly IP dose. MMD at baseline was the number of migraine days in the 4-week baseline phase. The least squares mean (LSM) was calculated using a linear mixed effects repeated measures model including treatment group, baseline value as covariate, stratification factors of region and prior preventive treatment failure, scheduled visit, and interaction of treatment group with scheduled visit. Participants were used as a random effect. As pre-specified in the Statistical Analysis Plan (SAP), only results from adolescents are presented.
5 secondary outcomes
Change From Baseline in Monthly Headache Days to Week 9 Through Week 12 (Month 3) of the DBTP
Time frame: Baseline to Week 12
Number of Participants With at Least 50% Reduction in MMD From Baseline to Week 9 Through Week 12 (Month 3) of the DBTP
Time frame: Baseline to Week 12
Change From Baseline in MMD to the Average of the First 3 Months (Week 1 Through Week 12) of the DBTP
Time frame: Baseline to Week 12
Change From Baseline in Monthly Average Severity of Migraine Attacks to Week 9 Through Week 12 (Month 3) of the DBTP
Time frame: Baseline to Week 12
Change From Baseline in Migraine-related Disability and Productivity as Measured by the Modified Pediatric Migraine Disability Assessment (PedMIDAS) to Week 9 Through Week 12 (Month 3) of the DBTP
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
101 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erenumab Dose 1, Erenumab Dose 2 and Erenumab Dose 3 in people with Migraine, run by Amgen at 101 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in United States, Japan, Poland, United Kingdom, Hungary and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in MMD to Week 9 Through Week 12 (Month 3) of the DBTP (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.