Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine (OASIS(EM))

March 20, 2024 updated by: Amgen

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])

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).

Study Overview

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

Interventional

Enrollment (Estimated)

456

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Brussel, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel
      • Mechelen, Belgium, 2800
        • Recruiting
        • Algemeen Ziekenhuis Sint-Maarten
      • Saint Nicolas, Belgium, 4420
        • Recruiting
        • Docteur Simona Sava srl
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C9
        • Recruiting
        • Stollery Childrens Hospital
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Recruiting
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L1
        • Recruiting
        • Childrens Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • The Hospital For Sick Children
    • Antioquia
      • Medellín, Antioquia, Colombia, 050021
        • Completed
        • Fundacion Centro de Investigacion Clinica
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 111211
        • Terminated
        • Cafam
      • Bogota, Cundinamarca, Colombia, 111221
        • Recruiting
        • Fundacion Hospital Infantil Universitario De San Jose
      • Bogota, Cundinamarca, Colombia, 110221
        • Recruiting
        • Solano y Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia Uniendo
    • Santander
      • Bucaramanga, Santander, Colombia, 681017
        • Recruiting
        • Fundacion Cardiovascular de Colombia
      • Turku, Finland, 20100
        • Completed
        • Terveystalo Pulssi
      • Berlin, Germany, 13353
        • Recruiting
        • Charite - Universitaetsmedizin Berlin, Campus Virchow
      • Essen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen
      • Kiel, Germany, 24149
        • Recruiting
        • Schmerzklinik Kiel
      • Leipzig, Germany, 04107
        • Completed
        • Arzneimittelforschung Leipzig GmbH
      • Balassagyarmat, Hungary, 2660
        • Terminated
        • Dr Kenessey Albert Korhaz - Rendelointezet
      • Budapest, Hungary, 1083
        • Recruiting
        • Semmelweis Egyetem
      • Budapest, Hungary, 1026
        • Terminated
        • Dr Altmann Anna egyeni vallalkozo
      • Budapest, Hungary, 1027
        • Recruiting
        • High Tech Medical Kft
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont
      • Miskolc, Hungary, 3526
        • Terminated
        • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
      • Milano, Italy, 20133
        • Completed
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
      • Palermo, Italy, 90134
        • Recruiting
        • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
      • Roma, Italy, 00165
        • Recruiting
        • IRCCS Ospedale Pediatrico Bambino Gesu
    • Aichi
      • Nagoya-shi, Aichi, Japan, 451-0031
        • Recruiting
        • Josai Kids Clinic
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 730-8518
        • Terminated
        • Hiroshima City Hiroshima Citizens Hospital
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-0004
        • Terminated
        • Kitami Clinic
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 658-0064
        • Recruiting
        • Konan Medical Center
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 862-8505
        • Recruiting
        • Kumamoto City Hospital
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 600-8811
        • Recruiting
        • Tatsuoka Neurology Clinic
      • Kyoto-shi, Kyoto, Japan, 606-0851
        • Recruiting
        • Ishikawa Clinic
      • Kyoto-shi, Kyoto, Japan, 605-0981
        • Recruiting
        • Japanese Red Cross Kyoto Daiichi Hospital
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 982-0014
        • Recruiting
        • Sendai Headache and Neurology Clinic
    • Osaka
      • Osaka-shi, Osaka, Japan, 556-0017
        • Recruiting
        • Tominaga Hospital
    • Saitama
      • Saitama-shi, Saitama, Japan, 338-8577
        • Recruiting
        • Saitama Neuropsychiatric Institute
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Recruiting
        • Keio University Hospital
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
    • Yamaguchi
      • Hofu-shi, Yamaguchi, Japan, 747-0802
        • Recruiting
        • Nagamitsu Clinic
    • Yamanashi
      • Kai-shi, Yamanashi, Japan, 400-0124
        • Recruiting
        • Nagaseki Headache Clinic
      • Bialystok, Poland, 15-274
        • Terminated
        • Uniwersytecki Dzieciecy Szpital Kliniczny im Ludwika Zamenhofa w Bialymstoku
      • Bydgoszcz, Poland, 85-752
        • Recruiting
        • AthleticoMed
      • Gdansk, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
      • Lodz, Poland, 93-338
        • Completed
        • Instytut Centrum Zdrowia Matki Polki
      • Lublin, Poland, 20-109
        • Completed
        • Centrum Medyczne Luxmed Spzoo
      • Lublin, Poland, 20-701
        • Recruiting
        • Centrum Medyczne Hope Clinic Sebastian Szklener
      • Poznan, Poland, 61-731
        • Recruiting
        • Clinical Research Center Spzoo Medic-R Spolka Komandytowa
      • Poznan, Poland, 60-355
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Warszawa, Poland, 01-018
        • Recruiting
        • Dr Sekowska Leczenie Bolu
      • Warszawa, Poland, 02-121
        • Recruiting
        • Next Stage Spzoo
      • Wroclaw, Poland, 52-210
        • Recruiting
        • Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
      • Coimbra, Portugal, 3000-602
        • Recruiting
        • Centro Hospitalar e Universitario de Coimbra, EPE - Hospital Pediatrico de Coimbra
      • Lisboa, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
      • Lisboa, Portugal, 1500-650
        • Recruiting
        • Hospital da Luz, SA
      • Lisboa, Portugal, 1169-045
        • Recruiting
        • Centro Hospitalar Universitario de Lisboa Central, EPE - Hospital Dona Estefania
      • Dorado, Puerto Rico, 00646
        • Recruiting
        • Puerto Rico Health and Wellness Institute
      • Moscow, Russian Federation, 125047
        • Recruiting
        • LLC clinic Chaika
      • Moscow, Russian Federation, 119571
        • Terminated
        • FSBI Russian Children Clinical Hospital of the MoH RF
      • Novosibirsk, Russian Federation, 630004
        • Recruiting
        • LLC Sibneyromed
      • Saint Petersburg, Russian Federation, 191025
        • Terminated
        • LLC Medical Technologies
    • Andalucía
      • Sevilla, Andalucía, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen Del Rocio
    • Cataluña
      • Barcelona, Cataluña, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Cataluña, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d Hebron
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
      • Basel, Switzerland, 4031
        • Terminated
        • Universitaets-Kinderspital beider Basel
      • Zollikon, Switzerland, 8702
        • Completed
        • Kopfwehzentrum Hirslanden
      • Cardiff, United Kingdom, CF14 4XW
        • Terminated
        • Noahs Ark Childrens Hospital for Wales
      • Glasgow, United Kingdom, G51 4TF
        • Recruiting
        • Royal Hospital for Children
      • Liverpool, United Kingdom, L12 2AP
        • Terminated
        • Alder Hey Childrens Hospital
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital for Children
      • London, United Kingdom, SE1 7EU
        • Recruiting
        • Evelina Childrens Hospital
      • Oxford, United Kingdom, OX3 9DU
        • Completed
        • Oxford Childrens Hospital
    • California
      • San Diego, California, United States, 92108
        • Recruiting
        • Paradigm Clinical Research Center Inc
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Childrens Hospital Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Completed
        • Colorado Springs Neurological Associates
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Recruiting
        • New England Institute for Clinical Research
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Childrens National Health System
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • TrueBlue Clinical Research
      • Gulf Breeze, Florida, United States, 32561
        • Recruiting
        • Northwest Florida Clinical Research Group Limited Liability Company
      • Miami, Florida, United States, 33155
        • Completed
        • Nicklaus Childrens Hospital
      • Miami, Florida, United States, 33155
        • Recruiting
        • Nicklaus Childrens Hospital
      • West Palm Beach, Florida, United States, 33407
        • Completed
        • Premiere Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Rare Disease Research Center Pediatrics
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • CenExel iResearch, LLC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann and Robert H Lurie Childrens Hospital of Chicago
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Chicago Headache Center and Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Josephson Wallack Munshower Neurology
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Terminated
        • University of Maryland, Baltimore
    • Massachusetts
      • Worcester, Massachusetts, United States, 14226
        • Terminated
        • New England Regional Headache Center Inc
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Recruiting
        • Michigan Head Pain and Neurological Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Terminated
        • Clinical Research Institute Inc
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Childrens Mercy Hospital and Clinics
      • Saint Louis, Missouri, United States, 63141
        • Completed
        • Mercy Research
    • Nebraska
      • Hastings, Nebraska, United States, 68901
        • Recruiting
        • Meridian Clinical Research LLC
    • New York
      • Amherst, New York, United States, 14226
        • Terminated
        • Dent Neurosciences Research Center
      • New York, New York, United States, 10032
        • Terminated
        • Columbia University Medical Center
      • New York, New York, United States, 10001
        • Recruiting
        • Modern Migraine MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Childrens Hospital Medical Center
      • Cleveland, Ohio, United States, 44195
        • Terminated
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Nationwide Childrens Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Childrens Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15236
        • Completed
        • Preferred Primary Care Physicians, Inc
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Recruiting
        • Palmetto Gastroenterology Clinical Research, LLC
    • Texas
      • Burleson, Texas, United States, 76028
        • Recruiting
        • Helios Clinical Research Inc
      • Frisco, Texas, United States, 75033
        • Recruiting
        • Stryde Consulting LLC
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Childrens Specialty Group
    • West Virginia
      • Crab Orchard, West Virginia, United States, 25827
        • Recruiting
        • Vaught Neurological Services
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Terminated
        • Marshfield Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • AMG334
  • Aimovig®
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:
  • AMG 334
  • Aimovig®
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:
  • AMG 334
  • Aimovig®
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:
  • AMG 334
  • Aimovig®
Placebo Comparator: Placebo
Participants will be randomized to a placebo comparator.
Placebo matching dose for erenumab dose 1, 2 and 3.

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

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2019

Primary Completion (Estimated)

June 17, 2026

Study Completion (Estimated)

July 29, 2027

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

February 7, 2019

First Posted (Actual)

February 11, 2019

Study Record Updates

Last Update Posted (Estimated)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing 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 (or other new use) 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.

IPD Sharing 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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