Study to Evaluate the Efficacy and Safety of Erenumab (AM... | NCT01952574 | Trialant
NCT01952574
Sponsor
Amgen
Status
Completed
Last Update Posted
Oct 12, 2022Actual
Enrollment
483Actual
Phase
Phase 2
Conditions
Migraine
Interventions
Erenumab
Placebo
Erenumab PFS
Erenumab AI/Pen
Countries
United States
Canada
Denmark
Finland
Germany
Norway
Sweden
Protocol Section
Identification Module
NCT ID
NCT01952574
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
20120178
Secondary IDs
ID
Type
Description
Link
2012-005331-90
EudraCT Number
Brief Title
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Acronym
Not provided
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
Oct 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 6, 2013Actual
Primary Completion Date
Sep 25, 2014Actual
Completion Date
Nov 12, 2019Actual
First Submitted Date
Aug 30, 2013
First Submission Date that Met QC Criteria
Sep 27, 2013
First Posted Date
Sep 30, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 11, 2018
Results First Submitted that Met QC Criteria
Jun 11, 2018
Results First Posted Date
Jul 10, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 30, 2015
Certification/Extension First Submitted that Passed QC Review
Apr 30, 2015
Certification/Extension First Posted Date
May 19, 2015Estimated
Last Update Submitted Date
Oct 3, 2022
Last Update Posted Date
Oct 12, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A study to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days in participants with episodic migraine.
Detailed Description
The study is composed of an initial screening phase (up to 3 weeks), a 4-week baseline phase, a 12-week double-blind treatment phase (DBTP), an open-label treatment phase (OLTP) for up to 256 weeks, and an 8-week safety follow-up (12 weeks after the last dose of investigational product [IP]).
In the DBTP participants were to be randomized in a 3:2:2:2 ratio to placebo, erenumab 7 mg, erenumab 21 mg, or erenumab 70 mg.
During the open-label treatment phase, participants were to receive erenumab 70 mg QM from week 12 to week 264. After implementation of Protocol Amendment 3 (07 April 2016), participants remaining in the OLTP increased their dose to erenumab 140 mg QM up to week 264. The safety follow-up increased from an 8-week safety follow-up to a 12-week safety follow-up (16 weeks after the last dose of investigational product).
During the OLTP participants enrolled at sites in the United States could enroll in an optional clinical home use (CHU) substudy, per a country-specific protocol amendment dated 20 June 2016. Participants in the CHU substudy were to be randomized 1:1 into 1 of 2 treatment groups: erenumab 140 mg using a prefilled syringe or erenumab 140 mg using an autoinjector/pen. Day 1 of the CHU substudy corresponded with any OLTP study visit up through Week 256, as long as the participant had received at least 2 doses of erenumab 140 mg. During the CHU substudy, participants initially self-administered IP under site supervision on substudy day 1, and then self-administered IP at home on substudy days 29 and 57.
Conditions Module
Conditions
Migraine
Keywords
migraine, headache, prevention, prophylaxis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
483Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase.
In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
Drug: Erenumab
Drug: Placebo
Erenumab 7 mg QM
Experimental
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase.
In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
Drug: Erenumab
Erenumab 21 mg QM
Experimental
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase.
In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
Drug: Erenumab
Erenumab 70 mg QM
Experimental
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase.
In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Erenumab
Drug
Administered by study site staff once a month (QM) as a subcutaneous injection
Erenumab 21 mg QM
Erenumab 7 mg QM
Erenumab 70 mg QM
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Monthly Migraine Days at Week 12
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 as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.
4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab
To assess participants ability to administer a full dose of erenumab in home-use at day 29 (week 4) and day 57 (week 8), site staff called participants and asked whether the participant administered a full, partial, or no dose of erenumab. A full dose means that the entire volume of both prefilled syringes or autoinjector/pens were injected. Discontinued prior to dosing day indicates participants who had discontinued the investigational product and did not attempt to self-administer on day 29 or 57.
CHU substudy day 29 (week 4) and day 57 (week 8)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12
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 without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of double-blind treatment. At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
History of migraine for more than12 months prior to screening
Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening and during baseline phase
Headache frequency: < 15 headache days per month (with > 50% of the headache days being migraine days) in each of the 3 months prior to screening and during baseline phase
Demonstrated at least 80% compliance with the eDiary during baseline phase
Exclusion Criteria:
Older than 50 years of age at migraine onset
History of cluster headache or basilar or hemiplegic migraine headache
Unable to differentiate migraine from other headaches
No therapeutic response with > 2 of the following eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. Medication categories are:
Sun H, Dodick DW, Silberstein S, Goadsby PJ, Reuter U, Ashina M, Saper J, Cady R, Chon Y, Dietrich J, Lenz R. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Apr;15(4):382-90. doi: 10.1016/S1474-4422(16)00019-3. Epub 2016 Feb 12.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (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.
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.
Participants were randomized 3:2:2:2 to receive placebo, erenumab 7 mg, erenumab 21 mg, or erenumab 70 mg once a month (QM) in the double-blind phase. Randomization was stratified by region (North America vs. Europe).
During the open-label treatment phase, participants in the United States (US) could participate in an optional Clinical Home Use (CHU) substudy.
Recruitment Details
This study was conducted at 59 centers in North America (Canada, USA) and Europe (Denmark, Finland, Germany, Norway, Sweden, and Portugal).
The study consisted of a 12-week double-blind treatment phase (DBTP) and a 256-week open-label treatment phase (OLTP) followed by a safety follow-up of 8 to 12 weeks (12 -16 weeks after last dose). The OLTP portion of the study was not conducted in Norway.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
DBTP: Placebo QM
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
FG001
DBTP: Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Periods
Title
Milestones
Reasons Not Completed
Double-blind Treatment Phase
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
In the DBTP participants were randomized to one of four arms. In the optional CHU substudy participants were randomized into one of two treatment groups.
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Drug: Erenumab
CHU Substudy: Erenumab 140 mg PFS
Experimental
Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
Drug: Erenumab PFS
CHU Substudy: Erenumab 140 mg AI/Pen
Experimental
Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using an autoinjector/pen (AI)/pen) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
Drug: Erenumab AI/Pen
Placebo
AMG 334
Aimovigâ„¢
Placebo
Drug
Administered by study site staff once a month (QM) as a subcutaneous injection
Placebo
Erenumab PFS
Drug
Erenumab supplied in a single-use prefilled syringe for self-administration in the CHU substudy
CHU Substudy: Erenumab 140 mg PFS
Erenumab AI/Pen
Drug
Erenumab supplied in a single-use autoinjector/pen for self-administration in the CHU substudy
CHU Substudy: Erenumab 140 mg AI/Pen
4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Change From Baseline in Monthly Migraine Attacks at Week 12
A migraine attack is an episode of any qualified migraine headache or migraine specific medication intakes for aura only. A migraine attack that was interrupted by sleep or that temporarily remits and then recurs within 48 hours or an attack treated successfully with medication but that relapses within 48 hours was considered to be one attack.
The change from baseline in monthly migraine attacks was calculated as the number of migraine attacks during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine attacks during the 4-week baseline phase.
4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase
An adverse event (AE) is any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and laboratory value changes that require treatment or adjustment in current therapy.
AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03:
Mild; asymptomatic or mild symptoms
Moderate; minimal, local or noninvasive intervention indicated; limiting daily activities
Severe or medically significant but not immediately life-threatening; hospitalization indicated; disabling; limiting self-care
A serious adverse event is an AE that meets at least 1 of the following criteria:
fatal
life threatening
requires in-patient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event
From first dose of study drug in the double-blind treatment phase until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase.
Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase
An adverse event (AE) is any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and laboratory value changes that require treatment or adjustment in current therapy.
AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03:
Mild; asymptomatic or mild symptoms
Moderate; minimal, local or noninvasive intervention indicated; limiting daily activities
Severe or medically significant but not immediately life-threatening; hospitalization indicated; disabling; limiting self-care
A serious adverse event is an AE that meets at least 1 of the following criteria:
fatal
life threatening
requires in-patient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event
From first dose in the open-label treatment phase up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; a maximum of 268 weeks.
CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy
AEs were graded using the CTCAE version 4.03:
Mild; asymptomatic or mild symptoms
Moderate; minimal, local or noninvasive intervention indicated; limiting daily activities
Severe or medically significant but not immediately life-threatening; hospitalization indicated; disabling; limiting self-care
A serious adverse event is an AE that meets at least 1 of the following criteria:
fatal
life threatening
requires in-patient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event An adverse device effect is any AE related to the use of a medical device, including AEs resulting from insufficient or inadequate instructions for use, any malfunction of the device, or use error or from intentional misuse of the device.
From first dose in the CHU substudy to end of substudy (up to 12 weeks)
Number of Participants Who Developed Anti-erenumab Antibodies During the Double-blind Treatment Phase
Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding erenumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab.
Participants who developed anti-erenumab antibodies are participants who were negative or had no result at baseline but positive at any time postbaseline during the DBTP.
If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies.
12 weeks
Number of Participants Who Developed Anti-erenumab Antibodies During the Open-label Treatment Phase
Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding erenumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab.
Participants who developed anti-erenumab antibodies are participants who were negative prior to the first OLTP dose but positive at any time during the OLTP, or participants with no data prior to first dose in OLTP with any post-baseline positive results.
If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies.
From week 12 up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks.
Long Beach
California
90806
United States
Research Site
National City
California
91950
United States
Research Site
Newport Beach
California
92663
United States
Research Site
San Francisco
California
94109
United States
Research Site
Santa Monica
California
90404
United States
Research Site
Sherman Oaks
California
91403
United States
Research Site
Spring Valley
California
91978
United States
Research Site
Danbury
Connecticut
06810
United States
Research Site
Fairfield
Connecticut
06824
United States
Research Site
Stamford
Connecticut
06905
United States
Research Site
Bradenton
Florida
34205
United States
Research Site
Melbourne
Florida
32935
United States
Research Site
Palm Beach Gardens
Florida
33410
United States
Research Site
West Palm Beach
Florida
33407
United States
Research Site
Decatur
Georgia
30033
United States
Research Site
Wichita
Kansas
67207
United States
Research Site
Lexington
Kentucky
40513
United States
Research Site
Louisville
Kentucky
40213
United States
Research Site
Watertown
Massachusetts
02472
United States
Research Site
Worcester
Massachusetts
01605
United States
Research Site
Ann Arbor
Michigan
48104
United States
Research Site
Kalamazoo
Michigan
49009
United States
Research Site
Southfield
Michigan
48034
United States
Research Site
Plymouth
Minnesota
55441
United States
Research Site
Springfield
Missouri
65807
United States
Research Site
St Louis
Missouri
63141
United States
Research Site
Rochester
New York
14609
United States
Research Site
Greensboro
North Carolina
27405
United States
Research Site
Raleigh
North Carolina
27612
United States
Research Site
Philadelphia
Pennsylvania
19107
United States
Research Site
Nashville
Tennessee
37203
United States
Research Site
Arlington
Texas
76017
United States
Research Site
Austin
Texas
78731
United States
Research Site
Dallas
Texas
75214
United States
Research Site
Dallas
Texas
75231
United States
Research Site
Houston
Texas
77074
United States
Research Site
Salt Lake City
Utah
84106
United States
Research Site
Salt Lake City
Utah
84124
United States
Research Site
Falls Church
Virginia
22042
United States
Research Site
Virginia Beach
Virginia
23454
United States
Research Site
Toronto
Ontario
M4S 1Y2
Canada
Research Site
Montreal
Quebec
H2L 4M1
Canada
Research Site
Aarhus C
8000
Denmark
Research Site
Glostrup Municipality
2600
Denmark
Research Site
Helsinki
00100
Finland
Research Site
Mikkeli
50100
Finland
Research Site
Oulu
90220
Finland
Research Site
Tampere
33100
Finland
Research Site
Turku
20100
Finland
Research Site
Berlin
10117
Germany
Research Site
Berlin
10409
Germany
Research Site
Berlin
10435
Germany
Research Site
Bochum
44789
Germany
Research Site
Essen
45133
Germany
Research Site
Hamburg
20246
Germany
Research Site
Leipzig
04107
Germany
Research Site
Ã…lesund
6003
Norway
Research Site
Hamar
2317
Norway
Research Site
Sandvika
1337
Norway
Research Site
Stavanger
4005
Norway
Research Site
Falköping
521 37
Sweden
Research Site
Lund
222 22
Sweden
Research Site
Stockholm
112 45
Sweden
Research Site
Stockholm
114 33
Sweden
Research Site
Vällingby
162 68
Sweden
Background
Ashina M, Dodick D, Goadsby PJ, Reuter U, Silberstein S, Zhang F, Gage JR, Cheng S, Mikol DD, Lenz RA. Erenumab (AMG 334) in episodic migraine: Interim analysis of an ongoing open-label study. Neurology. 2017 Sep 19;89(12):1237-1243. doi: 10.1212/WNL.0000000000004391. Epub 2017 Aug 23.
Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick D, Rippon GA, Klatt J, Xue F, Chia V, Zhang F, Cheng S, Mikol DD. Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine. Cephalalgia. 2019 Oct;39(11):1455-1464. doi: 10.1177/0333102419854082. Epub 2019 May 30.
Background
Cheng S, Picard H, Zhang F, Eisele O, Mikol DD. Efficacy and safety of erenumab for migraine prevention: an overview. Japanese Journal of Headache. 2019; 45 : 493-505.
Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick DW, Xue F, Zhang F, Paiva da Silva Lima G, Cheng S, Mikol DD. Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol. 2021 May;28(5):1716-1725. doi: 10.1111/ene.14715. Epub 2021 Jan 20.
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.
Ashina M, Kudrow D, Reuter U, Dolezil D, Silberstein S, Tepper SJ, Xue F, Picard H, Zhang F, Wang A, Zhou Y, Hong F, Klatt J, Mikol DD. Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions. Cephalalgia. 2019 Dec;39(14):1798-1808. doi: 10.1177/0333102419888222. Epub 2019 Nov 10.
Ashina M, Goadsby PJ, Dodick DW, Tepper SJ, Xue F, Zhang F, Brennan F, Paiva da Silva Lima G. Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura: A Secondary Analysis of Randomized Clinical Trials. JAMA Neurol. 2022 Feb 1;79(2):159-168. doi: 10.1001/jamaneurol.2021.4678.
FG002
DBTP: Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
FG003
DBTP: Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
FG004
OLTP: Erenumab 70/140 mg QM
Participants received 70 mg erenumab QM from the beginning of the OLTP (week 12). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
FG005
CHU Substudy: Erenumab 140 mg by Prefilled Syringe
Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
FG006
CHU Substudy: Erenumab 140 mg Autoinjector/Pen
Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using an autoinjector (AI)/pen on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
FG000160 subjects
FG001108 subjects
FG002108 subjects
FG003107 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Received Study Drug
FG000153 subjects
FG001108 subjects
FG002105 subjects
FG003106 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
Completed double-blind treatment phase
FG000143 subjects
FG001105 subjects
FG00299 subjects
FG003101 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00017 subjects
FG0013 subjects
FG0029 subjects
FG0036 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0009 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Sponsor Decision
FG0006 subjects
FG0010 subjects
FG0025 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Open-label Treatment Phase
Type
Comment
Milestone Data
STARTED
Participants enrolled in Norway did not participate in the OLTP. In addition 12 participants who completed the DBTP withdrew consent prior to entering the OLTP.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004383 subjects
FG0050 subjects
FG0060 subjects
Received 70 mg Erenumab
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Received 140 mg Erenumab
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Clinical Home Use Substudy
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00542 subjects
FG00641 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
BG001
Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
BG002
Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
BG003
Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000160
BG001108
BG002108
BG003107
BG004483
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000160
ParticipantsBG001108
ParticipantsBG002108
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000160
ParticipantsBG001108
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000160
ParticipantsBG001108
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000160
ParticipantsBG001108
ParticipantsBG002
Region
Region is based on actual data collected at study baseline instead of randomization stratification.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000160
ParticipantsBG001108
ParticipantsBG002
Monthly Migraine Days
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 as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase.
Participants with available baseline data
Mean
Standard Deviation
migraine days/month
Title
Denominators
Categories
ParticipantsBG000160
ParticipantsBG001108
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Monthly Migraine Days at Week 12
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 as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.
Participants who received at least 1 dose of investigational product (IP) and had ≥ 4 migraine days during the 4-week baseline phase (efficacy analysis set), and with at least one change from baseline value in monthly migraine days.
Posted
Least Squares Mean
Standard Error
migraine days / month
4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
ID
Title
Description
OG000
Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG001
Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG002
Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG003
Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Units
Counts
Participants
OG000152
OG001107
OG00299
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.28± 0.31
OG001-2.18± 0.36
OG002-2.39± 0.38
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.
Generalized Linear Mixed Model
0.021
LS Mean Difference
-1.12
2-Sided
95
-2.06
-0.17
Superiority
To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.
Secondary
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12
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 without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of double-blind treatment. At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.
Participants who received at least 1 dose of investigational product and had ≥ 4 migraine days during the 4-week baseline phase (efficacy analysis set) with available data at week 12.
Posted
Number
percentage of participants
4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
ID
Title
Description
OG000
Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG001
Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Secondary
Change From Baseline in Monthly Migraine Attacks at Week 12
A migraine attack is an episode of any qualified migraine headache or migraine specific medication intakes for aura only. A migraine attack that was interrupted by sleep or that temporarily remits and then recurs within 48 hours or an attack treated successfully with medication but that relapses within 48 hours was considered to be one attack.
The change from baseline in monthly migraine attacks was calculated as the number of migraine attacks during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine attacks during the 4-week baseline phase.
Participants who received at least 1 dose of investigational product and had ≥ 4 migraine days during the 4-week baseline phase (efficacy analysis set), and with at least one change from baseline value in monthly migraine attacks.
Posted
Least Squares Mean
Standard Error
migraine attacks/month
4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
ID
Title
Description
OG000
Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG001
Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG002
Primary
CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab
To assess participants ability to administer a full dose of erenumab in home-use at day 29 (week 4) and day 57 (week 8), site staff called participants and asked whether the participant administered a full, partial, or no dose of erenumab. A full dose means that the entire volume of both prefilled syringes or autoinjector/pens were injected. Discontinued prior to dosing day indicates participants who had discontinued the investigational product and did not attempt to self-administer on day 29 or 57.
Participants enrolled in the CHU substudy who received at least 1 dose of investigational product in the substudy.
Posted
Count of Participants
Participants
CHU substudy day 29 (week 4) and day 57 (week 8)
ID
Title
Description
OG000
CHU Substudy: Erenumab 140 mg Prefilled Syringe
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
OG001
CHY SubStudy: Erenumab 140 mg Autoinjector/Pen
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using an autoinjector/pen (AI)/pen) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
Secondary
Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase
An adverse event (AE) is any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and laboratory value changes that require treatment or adjustment in current therapy.
AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03:
Mild; asymptomatic or mild symptoms
Moderate; minimal, local or noninvasive intervention indicated; limiting daily activities
Severe or medically significant but not immediately life-threatening; hospitalization indicated; disabling; limiting self-care
A serious adverse event is an AE that meets at least 1 of the following criteria:
fatal
life threatening
requires in-patient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event
Randomized participants who received at least one dose of investigational product (safety analysis set).
Posted
Count of Participants
Participants
From first dose of study drug in the double-blind treatment phase until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase.
ID
Title
Description
OG000
Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Secondary
Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase
An adverse event (AE) is any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and laboratory value changes that require treatment or adjustment in current therapy.
AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03:
Mild; asymptomatic or mild symptoms
Moderate; minimal, local or noninvasive intervention indicated; limiting daily activities
Severe or medically significant but not immediately life-threatening; hospitalization indicated; disabling; limiting self-care
A serious adverse event is an AE that meets at least 1 of the following criteria:
fatal
life threatening
requires in-patient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event
All participants who received at least one dose of investigational product in the open-label treatment phase (open-label treatment phase set).
Posted
Count of Participants
Participants
From first dose in the open-label treatment phase up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; a maximum of 268 weeks.
ID
Title
Description
OG000
OLTP: Erenumab 70 mg QM
Participants received 70 mg erenumab QM from week 12 until implementation of Protocol Amendment 3 (07 April 2016) in the open-label treatment phase; median duration of exposure was 104 weeks.
Secondary
CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy
AEs were graded using the CTCAE version 4.03:
Mild; asymptomatic or mild symptoms
Moderate; minimal, local or noninvasive intervention indicated; limiting daily activities
Severe or medically significant but not immediately life-threatening; hospitalization indicated; disabling; limiting self-care
A serious adverse event is an AE that meets at least 1 of the following criteria:
fatal
life threatening
requires in-patient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event An adverse device effect is any AE related to the use of a medical device, including AEs resulting from insufficient or inadequate instructions for use, any malfunction of the device, or use error or from intentional misuse of the device.
Participants enrolled in the CHU substudy who received at least 1 dose of investigational product in the substudy.
Posted
Count of Participants
Participants
From first dose in the CHU substudy to end of substudy (up to 12 weeks)
ID
Title
Description
OG000
CHU Substudy: Erenumab 140 mg Prefilled Syringe
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
Secondary
Number of Participants Who Developed Anti-erenumab Antibodies During the Double-blind Treatment Phase
Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding erenumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab.
Participants who developed anti-erenumab antibodies are participants who were negative or had no result at baseline but positive at any time postbaseline during the DBTP.
If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies.
Participants who received at least 1 dose of IP and with valid postbaseline antibody testing results.
Posted
Count of Participants
Participants
12 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG001
Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG002
Secondary
Number of Participants Who Developed Anti-erenumab Antibodies During the Open-label Treatment Phase
Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding erenumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab.
Participants who developed anti-erenumab antibodies are participants who were negative prior to the first OLTP dose but positive at any time during the OLTP, or participants with no data prior to first dose in OLTP with any post-baseline positive results.
If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies.
Participants who received at least 1 dose of IP in the OLTP and with valid antibody testing results during the OLTP.
Posted
Count of Participants
Participants
From week 12 up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks.
ID
Title
Description
OG000
Placebo / Erenumab 70/140 mg QM
Participants randomized to placebo in the double-blind treatment phase received 70 mg erenumab QM from week 12 in the open-label treatment phase. After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
OG001
Time Frame
Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
DBTP: Placebo QM
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
1
153
45
153
EG001
DBTP: Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
1
108
27
108
EG002
DBTP: Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
0
105
24
105
EG003
DBTP: Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
1
106
31
106
EG004
OLTP: Erenumab 70 mg QM
Participants received 70 mg erenumab QM from week 12 until implementation of Protocol Amendment 3 (07 April 2016) in the open-label treatment phase; median duration of exposure was 104 weeks.
30
383
220
383
EG005
OLTP: Erenumab 140 mg QM
After implementation of Protocol Amendment 3 (07 April 2016), participants still on study received erenumab 140 mg QM up to week 264 in the open-label treatment phase; median duration of exposure was 141 weeks.
25
250
172
250
EG006
OLTP: Erenumab 70/140 mg QM
Participants received 70 mg erenumab QM from the beginning of the OLTP (week 12). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
49
383
264
383
EG007
CHU Substudy: Erenumab 140 mg PFS
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
0
42
7
42
EG008
CHU Substudy: Erenumab 140 mg AI/Pen
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using an autoinjector/pen (AI)/pen) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
0
41
9
41
EG009
CHU Substudy: Total
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using a prefilled syringe or autoinjector/pen on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
0
83
16
83
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Vertigo
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG0031 affected106 at risk
EG0040 affected383 at risk
EG0051 affected250 at risk
EG0061 affected383 at risk
EG0070 affected42 at risk
EG0080 affected41 at risk
EG0090 affected83 at risk
Migraine
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Ovarian cyst ruptured
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0011 affected108 at risk
EG0020 affected105 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Hypertensive heart disease
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Developmental hip dysplasia
Congenital, familial and genetic disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Primary hyperaldosteronism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Visual impairment
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Abdominal adhesions
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Appendicitis noninfective
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Intra-abdominal haematoma
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Pancreatic cyst
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Peritoneal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Rectal prolapse
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Death
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Hepatic cyst
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Pneumonia klebsiella
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Tubo-ovarian abscess
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Metatarsalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Adenocarcinoma of the cervix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Invasive lobular breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Lung adenocarcinoma stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Optic neuritis
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Adjustment disorder
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Bladder prolapse
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Pelvi-ureteric obstruction
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Adnexa uteri cyst
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG00012 affected153 at risk
EG00110 affected108 at risk
EG0026 affected105 at risk
EG0036 affected106 at risk
EG00482 affected383 at risk
EG00559 affected250 at risk
EG006111 affected383 at risk
EG0070 affected42 at risk
EG0082 affected41 at risk
EG0092 affected83 at risk
Constipation
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected153 at risk
EG0010 affected108 at risk
EG0021 affected105 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected153 at risk
EG0013 affected108 at risk
EG0021 affected105 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Systematic Assessment
EG0003 affected153 at risk
EG0015 affected108 at risk
EG0022 affected105 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0005 affected153 at risk
EG0011 affected108 at risk
EG0024 affected105 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 affected153 at risk
EG0010 affected108 at risk
EG0020 affected105 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0002 affected153 at risk
EG0012 affected108 at risk
EG0021 affected105 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0003 affected153 at risk
EG0011 affected108 at risk
EG0022 affected105 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 affected153 at risk
EG0010 affected108 at risk
EG0021 affected105 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0005 affected153 at risk
EG0011 affected108 at risk
EG0020 affected105 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0004 affected153 at risk
EG0012 affected108 at risk
EG0024 affected105 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected153 at risk
EG0011 affected108 at risk
EG0022 affected105 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected153 at risk
EG0014 affected108 at risk
EG0021 affected105 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0003 affected153 at risk
EG0012 affected108 at risk
EG0021 affected105 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected153 at risk
EG0011 affected108 at risk
EG0022 affected105 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected153 at risk
EG0011 affected108 at risk
EG0020 affected105 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Amgen Inc.
866-572-6436
medinfo@amgen.com
ID
Term
D008881
Migraine Disorders
D006261
Headache
Ancestor Terms
ID
Term
D051270
Headache Disorders, Primary
D020773
Headache Disorders
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D010146
Pain
D009461
Neurologic Manifestations
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000605816
erenumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
383 subjects
FG0050 subjects
FG0060 subjects
250 subjects
FG0050 subjects
FG0060 subjects
221 subjects
FG0050 subjects
FG0060 subjects
162 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG004121 subjects
FG0050 subjects
FG0060 subjects
Decision by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00417 subjects
FG0050 subjects
FG0060 subjects
Missing
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0044 subjects
FG0050 subjects
FG0060 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00419 subjects
FG0050 subjects
FG0060 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG00539 subjects
FG00640 subjects
0 subjects
FG0053 subjects
FG0061 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Decision by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0061 subjects
107
ParticipantsBG004483
Title
Measurements
BG00041.4± 10.0
BG00140.3± 10.9
BG00239.9± 12.3
BG00342.6± 9.9
BG00441.1± 10.8
108
ParticipantsBG003107
ParticipantsBG004483
Title
Measurements
Female
BG000132
BG00188
BG00287
BG00382
BG004389
Male
BG00028
BG00120
BG00221
BG00325
BG004
108
ParticipantsBG003107
ParticipantsBG004483
Title
Measurements
Hispanic or Latino
BG00011
BG0019
BG0029
BG0031
BG00430
Not Hispanic or Latino
BG000149
BG00199
BG00299
BG003106
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
108
ParticipantsBG003107
ParticipantsBG004483
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
Asian
BG0002
BG0010
BG0021
BG0031
BG004
Black or African American
BG00013
BG00110
BG0027
BG0032
BG004
Native Hawaiian or other Pacific Islander
BG0001
BG0010
BG0020
BG0030
BG004
White
BG000142
BG00197
BG002100
BG003103
BG004
Multiple
BG0000
BG0010
BG0020
BG0031
BG004
Other
BG0002
BG0011
BG0020
BG0030
BG004
108
ParticipantsBG003107
ParticipantsBG004483
Title
Measurements
North America
BG00085
BG00158
BG00258
BG00358
BG004259
Europe
BG00075
BG00150
BG00250
BG00349
BG004
ParticipantsBG002108
ParticipantsBG003106
ParticipantsBG004482
Title
Measurements
BG0008.77± 2.72
BG0018.62± 2.79
BG0028.93± 2.88
BG0038.58± 2.49
BG0048.73± 2.72
104
-3.40
± 0.37
OG000
OG002
The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.
Generalized Linear Mixed Model
0.83
LS Mean Difference
-0.10
2-Sided
95
-1.07
0.86
Superiority
To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.
OG000
OG001
The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.
Generalized Linear Mixed Model
0.82
LS Mean Difference
0.11
2-Sided
92
-0.83
1.05
Superiority
To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.
OG002
Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG003
Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Units
Counts
Participants
OG000144
OG001104
OG00293
OG00399
Title
Denominators
Categories
Title
Measurements
OG00029.9
OG00128.8
OG00234.4
OG00346.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one percent change from baseline value in monthly migraine days (152 participants in the placebo group and 104 in the erenumab 70 mg group)
Generalised Linear Mixed Model
Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.
0.011
Odds Ratio (OR)
2.00
2-Sided
95
1.17
3.42
Superiority
OG000
OG002
The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 99 in the erenumab 21 mg group)
Generalized Linear Mixed Model
Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.
0.44
Odds Ratio (OR)
1.25
2-Sided
95
0.71
2.18
Superiority
OG000
OG001
The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 107 in the erenumab 7 mg group)
Generalized Linear Mixed Model
Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.
0.80
Odds Ratio (OR)
0.93
2-Sided
95
0.53
1.63
Superiority
Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG003
Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Units
Counts
Participants
OG000152
OG001107
OG00299
OG003104
Title
Denominators
Categories
Title
Measurements
OG000-1.44± 0.17
OG001-1.07± 0.20
OG002-1.42± 0.21
OG003-1.84± 0.20
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Generalized Linear Mixed Model
Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.
0.13
LS Mean Difference
-0.40
2-Sided
95
-0.92
0.12
Superiority
OG000
OG002
Generalized Linear Mixed Model
Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.
0.95
LS Mean Difference
0.02
2-Sided
95
-0.51
0.54
Superiority
OG000
OG001
Generalized Linear Mixed Model
Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.
0.16
LS Mean Difference
0.37
2-Sided
95
-0.14
0.87
Superiority
Units
Counts
Participants
OG00042
OG00141
Title
Denominators
Categories
Day 29 (week 4)
Title
Measurements
Full dose
OG00039
OG00141
Partial dose
OG0001
OG0010
Discontinued prior to dosing day
OG0002
OG0010
Day 57 (week 8)
Title
Measurements
Full dose
OG00039
OG00139
Partial dose
OG0000
OG001
OG001
Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG002
Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG003
Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Units
Counts
Participants
OG000153
OG001108
OG002105
OG003106
Title
Denominators
Categories
Any adverse event (AE)
Title
Measurements
OG00081
OG00157
OG00255
OG00357
Serious adverse events (SAEs)
Title
Measurements
OG0001
OG0011
OG0020
OG003
AE leading to discontinuation of IP
Title
Measurements
OG0002
OG0012
OG0022
OG003
AE Grade ≥ 2
Title
Measurements
OG00036
OG00131
OG00225
OG003
AE Grade ≥ 3
Title
Measurements
OG0003
OG0013
OG0023
OG003
AE Grade ≥ 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Fatal adverse events
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
OLTP: Erenumab 140 mg QM
After implementation of Protocol Amendment 3 (07 April 2016), participants still on study received erenumab 140 mg QM up to week 264 in the open-label treatment phase; median duration of exposure was 141 weeks.
OG002
OLTP: Erenumab 70/140 mg QM
Participants received 70 mg erenumab QM from the beginning of the OLTP (week 12). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
Units
Counts
Participants
OG000383
OG001250
OG002383
Title
Denominators
Categories
Any adverse event (AE)
Title
Measurements
OG000323
OG001216
OG002340
Serious adverse events (SAEs)
Title
Measurements
OG00030
OG00125
OG00249
AE leading to discontinuation of IP
Title
Measurements
OG00016
OG0012
OG00218
AE Grade ≥ 2
Title
Measurements
OG000249
OG001180
OG002286
AE Grade ≥ 3
Title
Measurements
OG00055
OG00140
OG00283
AE Grade ≥ 4
Title
Measurements
OG0001
OG0013
OG0024
Fatal adverse events
Title
Measurements
OG0001
OG0011
OG0022
OG001
CHY SubStudy: Erenumab 140 mg Autoinjector/Pen
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using an autoinjector/pen (AI)/pen) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
Units
Counts
Participants
OG00042
OG00141
Title
Denominators
Categories
Any adverse event
Title
Measurements
OG00013
OG00117
AE Grade ≥ 2
Title
Measurements
OG0007
OG00110
AE Grade ≥ 3
Title
Measurements
OG0001
OG0012
AE Grade ≥ 4
Title
Measurements
OG0000
OG0010
Serious adverse events
Title
Measurements
OG0000
OG0010
Leading to discontinuation of IP
Title
Measurements
OG0000
OG0010
Fatal adverse events
Title
Measurements
OG0000
OG0010
Injection site reactions
Title
Measurements
OG0004
OG0012
Adverse device effects
Title
Measurements
OG0002
OG0012
Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
OG003
Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Units
Counts
Participants
OG000149
OG001107
OG002104
OG003106
Title
Denominators
Categories
Developed binding antibodies
Title
Measurements
OG0000
OG00113
OG00212
OG0038
Developed neutralizing antibodies
Title
Measurements
OG0000
OG0015
OG0023
OG003
Erenumab 7 mg QM / Erenumab 70/140 mg QM
Participants randomized to erenumab 7 mg in the double-blind treatment phase received 70 mg erenumab QM from week 12 in the open-label treatment phase. After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
OG002
Erenumab 21 mg QM / Erenumab 70/140 mg QM
Participants randomized to erenumab 21 mg in the double-blind treatment phase received 70 mg erenumab QM from week 12 in the open-label treatment phase. After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
OG003
Erenumab 70 mg QM / Erenumab 70/140 mg QM
Participants randomized to erenumab 70 mg in the double-blind treatment phase received 70 mg erenumab QM from week 12 in the open-label treatment phase. After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.