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Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine (OASIS(CM))

Primary Purpose

Migraine

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Erenumab Dose 1
Erenumab Dose 2
Erenumab Dose 3
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Headache, Prevention, Pediatric, Chronic Migraine

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.
  • Subject'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 (subjects 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 subject 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).

Key Exclusion Criteria:

  • History of cluster headache or hemiplegic migraine headache.
  • Chronic migraine with continuous pain, in which the subject 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 subject is at risk of self-harm or harm to others.
  • History of major psychiatric disorder. Subjects with anxiety disorder and/or mild major depressive disorder (Patient Health Questionnaire Modified for Adolescents [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. Subjects must have been on a stable dose within the 3 months before the start of the baseline phase.

Sites / Locations

  • Paradigm Clinical Research - La MesaRecruiting
  • Childrens Hospital ColoradoRecruiting
  • Colorado Springs Neurological Associates
  • New England Institute for Clinical ResearchRecruiting
  • Childrens National Health SystemRecruiting
  • TrueBlue Clinical ResearchRecruiting
  • Northwest Florida Clinical Research Group Limited Liability CompanyRecruiting
  • Nicklaus Childrens Hospital
  • Premiere Research Institute
  • CenExel iResearch, LLCRecruiting
  • Ann and Robert H Lurie Childrens Hospital of ChicagoRecruiting
  • Josephson Wallack Munshower NeurologyRecruiting
  • University of Maryland, BaltimoreRecruiting
  • New England Regional Headache Center Inc
  • Michigan Head Pain and Neurological InstituteRecruiting
  • Clinical Research Institute Inc
  • Childrens Mercy Hospital and ClinicsRecruiting
  • Mercy Research
  • Meridian Clinical Research LLCRecruiting
  • Dent Neurosciences Research Center
  • Modern Migraine MDRecruiting
  • Columbia University Medical CenterRecruiting
  • Cincinnati Childrens Hospital Medical CenterRecruiting
  • Cleveland Clinic
  • Nationwide Childrens HospitalRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Childrens Hospital of PhiladelphiaRecruiting
  • Preferred Primary Care Physicians, Inc
  • Palmetto Gastroenterology Clinical Research, LLCRecruiting
  • Childrens Specialty GroupRecruiting
  • Vaught Neurological ServicesRecruiting
  • Marshfield Clinic
  • Universitair Ziekenhuis BrusselRecruiting
  • Docteur Simona Sava srlRecruiting
  • Stollery Childrens HospitalRecruiting
  • London Health Sciences CentreRecruiting
  • Childrens Hospital of Eastern OntarioRecruiting
  • The Hospital For Sick ChildrenRecruiting
  • Fundacion Centro de Investigacion ClinicaRecruiting
  • Solano y Terront Servicios Medicos Ltda - Unidad Integral de Endocrinologia UniendoRecruiting
  • Cafam
  • Fundacion Hospital Infantil Universitario De San JoseRecruiting
  • Fundacion Cardiovascular de ColombiaRecruiting
  • Terveystalo Pulssi
  • Charite - Universitaetsmedizin Berlin, Campus VirchowRecruiting
  • Universitaetsklinikum EssenRecruiting
  • Schmerzklinik KielRecruiting
  • Arzneimittelforschung Leipzig GmbH
  • Dr Kenessey Albert Korhaz - Rendelointezet
  • Dr Altmann Anna egyeni vallalkozo
  • High Tech Medical KftRecruiting
  • Semmelweis EgyetemRecruiting
  • Debreceni Egyetem Klinikai KozpontRecruiting
  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
  • Fondazione IRCCS Istituto Neurologico Carlo BestaRecruiting
  • Azienda ospedaliera di rilievo nazionale e di alta specializzazione Civico di Cristina BenfratelliRecruiting
  • Fondazione Istituto Neurologico Nazionale C Mondino IRCCSRecruiting
  • IRCCS Ospedale Pediatrico Bambino GesuRecruiting
  • Josai Kids ClinicRecruiting
  • Hiroshima City Hiroshima Citizens Hospital
  • Kitami Clinic
  • Konan Medical CenterRecruiting
  • Kumamoto City HospitalRecruiting
  • Tatsuoka Neurology ClinicRecruiting
  • Japanese Red Cross Kyoto Daiichi HospitalRecruiting
  • Sendai Headache and Neurology ClinicRecruiting
  • Tominaga HospitalRecruiting
  • Saitama Neuropsychiatric InstituteRecruiting
  • Tokyo Headache ClinicRecruiting
  • Tokyo Medical University HospitalRecruiting
  • Nagamitsu ClinicRecruiting
  • Nagaseki Headache ClinicRecruiting
  • Uniwersyteckie Centrum Kliniczne
  • Instytut Centrum Zdrowia Matki Polki
  • Centrum Medyczne Luxmed Spzoo
  • Centrum Medyczne Hope Clinic Sebastian SzklenerRecruiting
  • Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
  • Clinical Research Center Spzoo Medic-R Spolka KomandytowaRecruiting
  • Dr Sekowska Leczenie BoluRecruiting
  • Next Stage SpzooRecruiting
  • Migre Polskie Centrum Leczenia Migreny Anna Gryglas-DworakRecruiting
  • Puerto Rico Health InstituteRecruiting
  • FSBI Russian Children Clinical Hospital of the MoH RFRecruiting
  • LLC clinic ChaikaRecruiting
  • LLC SibneyromedRecruiting
  • LLC Medical Technologies
  • Noahs Ark Childrens Hospital for WalesRecruiting
  • Royal Hospital for ChildrenRecruiting
  • Alder Hey Childrens Hospital
  • Evelina Childrens HospitalRecruiting
  • Great Ormond Street Hospital for ChildrenRecruiting
  • Oxford Childrens Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dose Level 1

Dose Level 2

Placebo

Arm Description

Subjects will be randomized to one of two doses determined by their body weight at Day 1.

Subjects will be randomized to one of two doses determined by their body weight at Day 1.

Outcomes

Primary Outcome Measures

Change from baseline in monthly migraine days (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 the double-blind treatment period (DBTP).

Secondary Outcome Measures

Change in monthly headache days from baseline
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 double-blind treatment period (DBTP)
Proportion of subjects with at least 50% reduction in monthly migraine days (MMDs) from baseline
To evaluate the effect of erenumab compared with placebo on the proportion of subjects with at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP)
Change in monthly migraine days (MMDs) from baseline to the average of the first 3 months
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 double-blind treatment period (DBTP).
Change in monthly migraine days (MMDs) from baseline to the average of the first 6 months
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the 6 month (week 1 through week 24) double-blind treatment period (DBTP).
Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)
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 double-blind treatment period (DBTP). This will be measured in an electronic diary (eDiary) with a visual analogue scale.
Change from baseline in migraine-related disability and productivity
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 Pediatric Migraine Disability Assessment Questionnaire (modified PedMIDAS) to month 3 of the double-blind treatment period (DBTP).

Full Information

First Posted
January 29, 2019
Last Updated
October 12, 2023
Sponsor
Amgen
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT03832998
Brief Title
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
Acronym
OASIS(CM)
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])
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
June 29, 2026 (Anticipated)
Study Completion Date
June 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
Collaborators
Novartis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 subjects 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 double-blind treatment phase (24 weeks) 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 286 participants (256 adolescents and 30 children).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Headache, Prevention, Pediatric, Chronic Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
286 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Level 1
Arm Type
Experimental
Arm Description
Subjects will be randomized to one of two doses determined by their body weight at Day 1.
Arm Title
Dose Level 2
Arm Type
Experimental
Arm Description
Subjects will be randomized to one of two doses determined by their body weight at Day 1.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Erenumab Dose 1
Other Intervention Name(s)
AMG 334, Aimovig®
Intervention Description
Subjects in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
Intervention Type
Drug
Intervention Name(s)
Erenumab Dose 2
Other Intervention Name(s)
AMG 334, Aimovig®
Intervention Description
Subjects 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.
Intervention Type
Drug
Intervention Name(s)
Erenumab Dose 3
Other Intervention Name(s)
AMG 334, Aimovig®
Intervention Description
Subjects in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo matching dose for erenumab dose 1, 2 and 3.
Primary Outcome Measure Information:
Title
Change from baseline in monthly migraine days (MMDs)
Description
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).
Time Frame
Baseline through week 12 of the double blind treatment phase
Secondary Outcome Measure Information:
Title
Change in monthly headache days from baseline
Description
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 double-blind treatment period (DBTP)
Time Frame
Baseline through week 12 of the double blind treatment phase
Title
Proportion of subjects with at least 50% reduction in monthly migraine days (MMDs) from baseline
Description
To evaluate the effect of erenumab compared with placebo on the proportion of subjects with at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP)
Time Frame
Baseline through week 12 of the double blind treatment phase
Title
Change in monthly migraine days (MMDs) from baseline to the average of the first 3 months
Description
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 double-blind treatment period (DBTP).
Time Frame
Baseline through week 12 of the double blind treatment phase
Title
Change in monthly migraine days (MMDs) from baseline to the average of the first 6 months
Description
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the 6 month (week 1 through week 24) double-blind treatment period (DBTP).
Time Frame
Completion of double blind treatment phase at 24 weeks
Title
Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)
Description
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 double-blind treatment period (DBTP). This will be measured in an electronic diary (eDiary) with a visual analogue scale.
Time Frame
Baseline through week 12 of the double blind treatment phase
Title
Change from baseline in migraine-related disability and productivity
Description
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 Pediatric Migraine Disability Assessment Questionnaire (modified PedMIDAS) to month 3 of the double-blind treatment period (DBTP).
Time Frame
Baseline through week 12 of the double blind treatment phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Subject'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 (subjects 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 subject 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). Key Exclusion Criteria: History of cluster headache or hemiplegic migraine headache. Chronic migraine with continuous pain, in which the subject 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 subject is at risk of self-harm or harm to others. History of major psychiatric disorder. Subjects with anxiety disorder and/or mild major depressive disorder (Patient Health Questionnaire Modified for Adolescents [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. Subjects must have been on a stable dose within the 3 months before the start of the baseline phase.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Paradigm Clinical Research - La Mesa
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Springs Neurological Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Terminated
Facility Name
New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
TrueBlue Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Florida Clinical Research Group Limited Liability Company
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Individual Site Status
Recruiting
Facility Name
Nicklaus Childrens Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Terminated
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Terminated
Facility Name
CenExel iResearch, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Individual Site Status
Recruiting
Facility Name
Ann and Robert H Lurie Childrens Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Josephson Wallack Munshower Neurology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
New England Regional Headache Center Inc
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Terminated
Facility Name
Michigan Head Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute Inc
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Individual Site Status
Terminated
Facility Name
Childrens Mercy Hospital and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Terminated
Facility Name
Meridian Clinical Research LLC
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Individual Site Status
Recruiting
Facility Name
Dent Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Terminated
Facility Name
Modern Migraine MD
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Terminated
Facility Name
Nationwide Childrens Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Preferred Primary Care Physicians, Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Individual Site Status
Terminated
Facility Name
Palmetto Gastroenterology Clinical Research, LLC
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens Specialty Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Name
Vaught Neurological Services
City
Crab Orchard
State/Province
West Virginia
ZIP/Postal Code
25827
Country
United States
Individual Site Status
Recruiting
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Individual Site Status
Terminated
Facility Name
Universitair Ziekenhuis Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Docteur Simona Sava srl
City
Saint Nicolas
ZIP/Postal Code
4420
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Stollery Childrens Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C9
Country
Canada
Individual Site Status
Recruiting
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Childrens Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Hospital For Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fundacion Centro de Investigacion Clinica
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050021
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Solano y Terront Servicios Medicos Ltda - Unidad Integral de Endocrinologia Uniendo
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Cafam
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
111211
Country
Colombia
Individual Site Status
Terminated
Facility Name
Fundacion Hospital Infantil Universitario De San Jose
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
111221
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Fundacion Cardiovascular de Colombia
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
681017
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Terveystalo Pulssi
City
Turku
ZIP/Postal Code
20100
Country
Finland
Individual Site Status
Completed
Facility Name
Charite - Universitaetsmedizin Berlin, Campus Virchow
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Schmerzklinik Kiel
City
Kiel
ZIP/Postal Code
24149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Arzneimittelforschung Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Individual Site Status
Completed
Facility Name
Dr Kenessey Albert Korhaz - Rendelointezet
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Individual Site Status
Terminated
Facility Name
Dr Altmann Anna egyeni vallalkozo
City
Budapest
ZIP/Postal Code
1026
Country
Hungary
Individual Site Status
Terminated
Facility Name
High Tech Medical Kft
City
Budapest
ZIP/Postal Code
1064
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Terminated
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda ospedaliera di rilievo nazionale e di alta specializzazione Civico di Cristina Benfratelli
City
Palermo
ZIP/Postal Code
90134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesu
City
Roma
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Name
Josai Kids Clinic
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
451-0031
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima City Hiroshima Citizens Hospital
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Individual Site Status
Terminated
Facility Name
Kitami Clinic
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0004
Country
Japan
Individual Site Status
Terminated
Facility Name
Konan Medical Center
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
658-0064
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kumamoto City Hospital
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
862-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tatsuoka Neurology Clinic
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
600-8811
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Kyoto Daiichi Hospital
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
605-0981
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sendai Headache and Neurology Clinic
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
982-0014
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tominaga Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
556-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Neuropsychiatric Institute
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
338-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Headache Clinic
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
151-0051
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagamitsu Clinic
City
Hofu-shi
State/Province
Yamaguchi
ZIP/Postal Code
747-0802
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagaseki Headache Clinic
City
Kai-shi
State/Province
Yamanashi
ZIP/Postal Code
400-0124
Country
Japan
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Completed
Facility Name
Instytut Centrum Zdrowia Matki Polki
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne Luxmed Spzoo
City
Lublin
ZIP/Postal Code
20-109
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne Hope Clinic Sebastian Szklener
City
Lublin
ZIP/Postal Code
20-701
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
City
Poznan
ZIP/Postal Code
61-731
Country
Poland
Individual Site Status
Recruiting
Facility Name
Dr Sekowska Leczenie Bolu
City
Warszawa
ZIP/Postal Code
01-018
Country
Poland
Individual Site Status
Recruiting
Facility Name
Next Stage Spzoo
City
Warszawa
ZIP/Postal Code
02-121
Country
Poland
Individual Site Status
Recruiting
Facility Name
Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
City
Wroclaw
ZIP/Postal Code
52-210
Country
Poland
Individual Site Status
Recruiting
Facility Name
Puerto Rico Health Institute
City
Dorado
ZIP/Postal Code
00646
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
FSBI Russian Children Clinical Hospital of the MoH RF
City
Moscow
ZIP/Postal Code
119571
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
LLC clinic Chaika
City
Moscow
ZIP/Postal Code
125047
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
LLC Sibneyromed
City
Novosibirsk
ZIP/Postal Code
630004
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
LLC Medical Technologies
City
Saint Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Noahs Ark Childrens Hospital for Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Hospital for Children
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Alder Hey Childrens Hospital
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Individual Site Status
Terminated
Facility Name
Evelina Childrens Hospital
City
London
ZIP/Postal Code
SE1 7EU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Great Ormond Street Hospital for Children
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Oxford Childrens Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 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. 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.
IPD Sharing URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine

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