Back to resultsA Controlled Trial of Erenumab in Migraine Prevention
Primary Purpose
Migraine
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Erenumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
- Japanese subjects greater than or equal to 20 to less than or equal to 65 years of age upon entry into screening.
- History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report
Migraine frequency: Chronic Migraine (CM) or Episodic Migraine (EM) over the 3 months before screening based on the following criteria:
- CM is defined as greater than or equal to 15 headache days per month of which greater than or equal to 8 headache days on average across the 3 months meet criteria as migraine days
- EM is defined as less than 15 headache days per month of which at least 4 or more headache days on average across the 3 months meet criteria as migraine days
Exclusion Criteria:
- Subjects greater than 50 years of age at migraine onset.
- History of cluster headache or hemiplegic migraine headache.
- Unable to differentiate migraine from other headaches.
- Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period.
- Malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
Other exclusion criteria may apply
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Erenumab
Placebo
Arm Description
Participants were to receive erenumab 70 mg once a month for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
Participants were to receive placebo to erenumab once a month for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
Outcomes
Primary Outcome Measures
Change From Baseline in Mean Monthly Migraine Days (MMD) Over Months 4, 5, and 6 of the Double-blind Treatment Period
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura, lasting for ≥ 4 hours, and meeting at least 1 of the following criteria:
≥ 2 of the following pain features:
unilateral
throbbing
moderate to severe
exacerbated with exercise/physical activity
≥ 1 of the following associated symptoms:
nausea
vomiting
photophobia and phonophobia
The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period minus the number of migraine days during the 4-week baseline period.
Secondary Outcome Measures
Percentage of Participants With at Least a 50% Reduction From Baseline in Mean Monthly Migraine Days Over Months 4, 5, and 6 of the DBTP
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura, lasting for ≥ 4 hours, and meeting at least 1 of the following criteria:
≥ 2 of the following pain features:
unilateral
throbbing
moderate to severe
exacerbated with exercise/physical activity
≥ 1 of the following associated symptoms:
nausea
vomiting
photophobia and phonophobia
Change From Baseline in Mean Monthly Acute Migraine-specific Medication Treatment Days Over Months 4, 5, and 6 of the DBTP
An acute migraine-specific medication treatment day is any calendar day during which a participant took a migraine-specific medication (e.g., triptan or ergotamine).
The change from baseline in monthly acute migraine-specific treatment days was calculated as the average number of migraine-specific treatment days per month during the last 3 months of the 24-week double-blind treatment period minus the number of migraine-specific treatment days during the 4-week baseline period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03812224
Brief Title
A Controlled Trial of Erenumab in Migraine Prevention
Official Title
A Phase 3 Japanese Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 12, 2019 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
November 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).
Detailed Description
Migraine prevention is an area of a large unmet medical need, with existing therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) receptor antagonism is a novel approach to migraine preventive therapy. Erenumab is a human monoclonal antibody against canonical CGRP receptor. The present study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).
The study consists of a screening period (up to 7 weeks, including a 4-week baseline period), a 24-week double-blind treatment period (DBTP), a 28-week open-label treatment period (OLTP), and an 8-week safety follow-up period (12 weeks after the last dose of investigational product).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erenumab
Arm Type
Experimental
Arm Description
Participants were to receive erenumab 70 mg once a month for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants were to receive placebo to erenumab once a month for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
Intervention Type
Drug
Intervention Name(s)
Erenumab
Other Intervention Name(s)
AMG 334, Aimovig®
Intervention Description
Administered by subcutaneous injection once a month
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection once a month
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Monthly Migraine Days (MMD) Over Months 4, 5, and 6 of the Double-blind Treatment Period
Description
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura, lasting for ≥ 4 hours, and meeting at least 1 of the following criteria:
≥ 2 of the following pain features:
unilateral
throbbing
moderate to severe
exacerbated with exercise/physical activity
≥ 1 of the following associated symptoms:
nausea
vomiting
photophobia and phonophobia
The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period minus the number of migraine days during the 4-week baseline period.
Time Frame
4-week baseline period and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least a 50% Reduction From Baseline in Mean Monthly Migraine Days Over Months 4, 5, and 6 of the DBTP
Description
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura, lasting for ≥ 4 hours, and meeting at least 1 of the following criteria:
≥ 2 of the following pain features:
unilateral
throbbing
moderate to severe
exacerbated with exercise/physical activity
≥ 1 of the following associated symptoms:
nausea
vomiting
photophobia and phonophobia
Time Frame
4-week baseline period and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period
Title
Change From Baseline in Mean Monthly Acute Migraine-specific Medication Treatment Days Over Months 4, 5, and 6 of the DBTP
Description
An acute migraine-specific medication treatment day is any calendar day during which a participant took a migraine-specific medication (e.g., triptan or ergotamine).
The change from baseline in monthly acute migraine-specific treatment days was calculated as the average number of migraine-specific treatment days per month during the last 3 months of the 24-week double-blind treatment period minus the number of migraine-specific treatment days during the 4-week baseline period.
Time Frame
4-week baseline period and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
Japanese subjects greater than or equal to 20 to less than or equal to 65 years of age upon entry into screening.
History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report
Migraine frequency: Chronic Migraine (CM) or Episodic Migraine (EM) over the 3 months before screening based on the following criteria:
CM is defined as greater than or equal to 15 headache days per month of which greater than or equal to 8 headache days on average across the 3 months meet criteria as migraine days
EM is defined as less than 15 headache days per month of which at least 4 or more headache days on average across the 3 months meet criteria as migraine days
Exclusion Criteria:
Subjects greater than 50 years of age at migraine onset.
History of cluster headache or hemiplegic migraine headache.
Unable to differentiate migraine from other headaches.
Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period.
Malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
Other exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
790-0925
Country
Japan
Facility Name
Research Site
City
Kasuga-shi
State/Province
Fukuoka
ZIP/Postal Code
816-0802
Country
Japan
Facility Name
Research Site
City
Kasuga-shi
State/Province
Fukuoka
ZIP/Postal Code
816-0824
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
730-0031
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
730-0845
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0003
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
007-0836
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8570
Country
Japan
Facility Name
Research Site
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
658-0064
Country
Japan
Facility Name
Research Site
City
Kahoku-gun
State/Province
Ishikawa
ZIP/Postal Code
929-0342
Country
Japan
Facility Name
Research Site
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Research Site
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
769-0103
Country
Japan
Facility Name
Research Site
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0844
Country
Japan
Facility Name
Research Site
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
211-8588
Country
Japan
Facility Name
Research Site
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Research Site
City
Kochi-shi
State/Province
Kochi
ZIP/Postal Code
780-8011
Country
Japan
Facility Name
Research Site
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
861-2101
Country
Japan
Facility Name
Research Site
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
862-8505
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
600-8811
Country
Japan
Facility Name
Research Site
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
982-0014
Country
Japan
Facility Name
Research Site
City
Oita-shi
State/Province
Oita
ZIP/Postal Code
870-0831
Country
Japan
Facility Name
Research Site
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
556-0017
Country
Japan
Facility Name
Research Site
City
Toyonaka-shi
State/Province
Osaka
ZIP/Postal Code
560-0012
Country
Japan
Facility Name
Research Site
City
Saga-shi
State/Province
Saga
ZIP/Postal Code
840-0806
Country
Japan
Facility Name
Research Site
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Research Site
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
338-8577
Country
Japan
Facility Name
Research Site
City
Tokorozawa-shi
State/Province
Saitama
ZIP/Postal Code
359-1141
Country
Japan
Facility Name
Research Site
City
Shizuoka-shi
State/Province
Shizuoka
ZIP/Postal Code
420-0853
Country
Japan
Facility Name
Research Site
City
Shimotsuga-gun
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Research Site
City
Chofu-shi
State/Province
Tokyo
ZIP/Postal Code
182-0006
Country
Japan
Facility Name
Research Site
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
Research Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0075
Country
Japan
Facility Name
Research Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Research Site
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
151-0051
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0017
Country
Japan
Facility Name
Research Site
City
Tottori-shi
State/Province
Tottori
ZIP/Postal Code
680-0045
Country
Japan
Facility Name
Research Site
City
Yonago-shi
State/Province
Tottori
ZIP/Postal Code
683-0033
Country
Japan
Facility Name
Research Site
City
Toyama-shi
State/Province
Toyama
ZIP/Postal Code
930-0803
Country
Japan
Facility Name
Research Site
City
Hofu-shi
State/Province
Yamaguchi
ZIP/Postal Code
747-0802
Country
Japan
Facility Name
Research Site
City
Yamaguchi-shi
State/Province
Yamaguchi
ZIP/Postal Code
754-0002
Country
Japan
Facility Name
Research Site
City
Kai-shi
State/Province
Yamanashi
ZIP/Postal Code
400-0124
Country
Japan
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
the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or
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 link below.
IPD Sharing URL
http://www.amgen.com/datasharing
Citations:
PubMed Identifier
35272533
Citation
Zhou Y, Zhang F, Starcevic Manning M, Hu Z, Hsu CP, Chen PW, Peng C, Loop B, Mytych DT, Paiva da Silva Lima G. Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions. Cephalalgia. 2022 Jul;42(8):749-760. doi: 10.1177/03331024221075621. Epub 2022 Mar 10.
Results Reference
background
PubMed Identifier
35201674
Citation
Hirata K, Takeshima T, Sakai F, Imai N, Matsumori Y, Tatsuoka Y, Numachi Y, Yoshida R, Peng C, Mikol DD, Lima GPDS, Cheng S. Early onset of efficacy with erenumab for migraine prevention in Japanese patients: Analysis of two randomized, double-blind, placebo-controlled studies. Brain Behav. 2022 Mar;12(3):e2526. doi: 10.1002/brb3.2526. Epub 2022 Feb 24.
Results Reference
background
Citation
Hiramatsu K, Onizuka Y, Hasebe M, Yoshida R, Numachi Y. Novel Drug for Migraine Prophylaxis: Mode of Action, Efficacy and Safety of Erenumab. Shinryo to Shinyaku (Med Cons New-Remed) 2021:58(11):797-832
Results Reference
background
PubMed Identifier
34537006
Citation
Hirata K, Sakai F, Takeshima T, Imai N, Matsumori Y, Yoshida R, Numachi Y, Peng C, Mikol DD, Cheng S. Efficacy and safety of erenumab in Japanese migraine patients with prior preventive treatment failure or concomitant preventive treatment: subgroup analyses of a phase 3, randomized trial. J Headache Pain. 2021 Sep 18;22(1):110. doi: 10.1186/s10194-021-01313-8.
Results Reference
background
PubMed Identifier
34153117
Citation
Takeshima T, Sakai F, Hirata K, Imai N, Matsumori Y, Yoshida R, Peng C, Cheng S, Mikol DD. Erenumab treatment for migraine prevention in Japanese patients: Efficacy and safety results from a Phase 3, randomized, double-blind, placebo-controlled study. Headache. 2021 Jun;61(6):927-935. doi: 10.1111/head.14138. Epub 2021 Jun 21.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Controlled Trial of Erenumab in Migraine Prevention
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