CompletedNCT02630459Updated Oct 12, 2022Results posted

A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention

A Phase 2 interventional study of Placebo and Erenumab in Migraine, sponsored by Amgen. Completed at 44 sites in Japan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-10-12.

Sponsored by Amgen · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 475
Allocation: Randomized
Ages: 20 Years to 65 Years
Sex: All

Study summary

Randomized, double-blind, placebo-controlled, parallel-group, multicenter study followed by an open-label treatment phase (OLTP). To evaluate the effect of erenumab (AMG 334) compared to placebo on the change from baseline in monthly migraine days.

Read the detailed description

This is a Phase 2, randomized, double-blind, placebo-controlled study in participants with episodic migraine. The study's double blind treatment phase (DBTP) is designed to evaluate if treatment with erenumab once a month for 6 months compared with placebo is effective in reducing the mean monthly migraine days. Additionally, this study will continue to evaluate the efficacy and safety of erenumab during the OLTP where participants will continue to receive active treatment monthly.

The study also includes a clinical home use (CHU) sub-study to assess a participant's ability to self-administer 140 mg of erenumab. Participants will be randomized 1:1 to use either 2 pre-filled 70 mg/mL autoinjector (AI)/pens or 1 pre-filled 140 mg/mL AI/pen. Participation in the substudy is optional, and no additional samples will be collected for the sub-study.

After implementation of Protocol Amendment 2, the dose of erenumab in the OLTP increased from 70 mg to 140 mg QM. Participants who had already completed week 48 remain on 70 mg QM, participants not yet starting the OLTP, or not yet completing the week 48 visit receive erenumab 140 mg QM for the remainder of the OLTP.

Conditions studied

Migraine

Browse trials for

Migraine Disorders 1,528

Keywords

Migraine Prevention
Headache
Prophylaxis

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 475 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria to be assessed prior to entering the subject into the initial screening and/or baseline phase:

Provided informed consent prior to initiation of any study-specific activities/procedures
History of migraine (with or without aura) for ≥ 12 months prior to screening according to the International Headache Society (IHS) Classification The International Classification of Headache Disorders (ICHD)-3 (Headache Classification Committee of the IHS, 2013),
Migraine frequency: ≥ 4 and \< 15 migraine days per month on average across the 3 months prior to screening,
Headache frequency: \< 15 headache days per month on average across the 3 months prior to screening.

Inclusion Criteria to be assessed during the baseline phase and confirmed prior to randomizing the subject into the double-blind treatment phase:

Demonstrated at least 80% compliance with the electronic Diary (eDiary),
Migraine frequency: ≥ 4 and \< 15 migraine days during the baseline phase based on the eDiary calculations,
Headache frequency: \< 15 headache days during the baseline phase based on the eDiary calculations.

Inclusion Criteria for the Clinical Home Use (CHU) Substudy:

Subjects must have provided informed consent for the substudy. Subjects enrolling in the CHU substudy must have received open-label 140 mg erenumab for at least 1 dose.

Exclusion Criteria:

Older than 50 years of age at migraine onset,
History of cluster headache or hemiplegic migraine headache,
Unable to differentiate migraine from other headaches,
No therapeutic response with > 2 of the following 7 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial: Category 1: Divalproex sodium, sodium valproate, Category 2: Topiramate, Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol), Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline),Category 5: Serotonin-norepinephrine reuptake inhibitors (for example: venlafaxine, desvenlafaxine, duloxetine, milnacipran), Category 6: Flunarizine, verapamil, lomerizine, Category 7: Lisinopril, candesartan,
Used a prohibited medication, device or procedure within 2 months prior to the start of the baseline phase or during the baseline phase,
Received botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline phase or during the baseline phase,
Taken the following for any indication in any month during the 2 months prior to the start of the baseline phase: Ergotamines or triptans on ≥ 10 days per month, or Simple analgesics (nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on ≥ 15 days per month, or Opioid- or butalbital-containing analgesics on ≥ 4 days per month,
Anticipated to require any excluded medication, device or procedure during the study,
Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain),
History of major psychiatric disorder (such as schizophrenia and bipolar disorder), or current evidence of depression based on a Beck Depression Inventory (BDI)-II total score > 19 at screening. Subjects with anxiety disorder and/or major depressive disorder are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Subjects must have been on a stable dose within the 3 months prior to the start of the baseline phase,
History of seizure disorder or other significant neurological conditions other than migraine. Note: A single childhood febrile seizure is not exclusionary,
Malignancy within the 5 years prior to screening, except non melanoma skin cancers, cervical or breast ductal carcinoma in situ,
Human immunodeficiency virus (HIV) infection by history,
Hepatic disease by history, or total bilirubin (TBL) ≥ 2.0 x upper limit of normal (ULN) or alanine transaminase (ALT) or aspartate aminotransferase (AST) ≥ 3.0 x ULN, as assessed by the central laboratory at initial screening, or evidence of acute or chronic hepatitis B or hepatitis C virus. Hepatitis status will be evaluated by testing for hepatitis B surface antigen (HepBsAg), total hepatitis B core antibody (HepBcAb) and hepatitis C antibody by the central laboratory at initial screening. Polymerase chain reaction (PCR) should be performed to confirm active disease only if total HepBcAb is positive and HepBsAg is negative or if C antibody is positive,
Myocardial infarction, stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening,
History or evidence of any other unstable or clinically significant medical condition that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion,
Subject has any clinically significant vital sign, laboratory, or electrocardiogram (ECG) abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation,
The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessed at screening,
Evidence of drug or alcohol abuse or dependence within 12 months prior to screening, based on medical records, patient self-report, or positive urine drug test performed during screening (with the exception of prescribed medications such as opioids or barbiturates),
Pregnant or breastfeeding, or is a female expecting to conceive during the study, including through 16 weeks after the last dose of investigational product,
Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with investigational product through 16 weeks after the last dose of investigational product,
Currently receiving treatment in another investigational device or drug study, or less than 90 days prior to screening since ending treatment on another investigational device or drug study(-ies),
Known sensitivity to any component of the investigational product (Refer to the Investigational Product Instruction Manual [IPIM] for details),
Previously randomized into an erenumab study,
Member of investigational site staff or relative of the investigator,
Unlikely to be able to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, independent completion of eDiary items) to the best of the subject's and investigator's knowledge.

Exclusion Criteria for the CHU Substudy:

Unreliability as a study participant based on the investigator's (or designee's) knowledge of the subject (eg, unwillingness to adhere to the protocol, unwilling to self-inject using an autoinjector (AI)/pen after review of the Instructions for Use). Subjects receiving erenumab 70 mg in the open-label phase are not eligible.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 475 participants (actual)

Study arms

Placebo comparator
Double Blind Treatment Phase (DBTP): Placebo
Participants received placebo by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Drug: Placebo
Experimental
DBTP: Erenumab 28 mg QM
Participants received erenumab 28 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Drug: Erenumab
Experimental
DBTP: Erenumab 70 mg QM
Participants received erenumab 70 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Drug: Erenumab
Experimental
DBTP: Erenumab 140 mg QM
Participants received erenumab 140 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Drug: Erenumab
Experimental
Open-Label Treatment Phase (OLTP): Erenumab 70-140 mg QM
Participants received an erenumab dose of 70 and/or 140 mg QM SC (depending on the participant's visit completion status after Institutional Review Board \[IRB\] approval of Protocol Amendment 2) in the OLTP for a total of 76 weeks.
Drug: Erenumab
Experimental
CHU Sub-Study: Two 70 mg/mL AI/pens
A subset of participants in the OLTP randomized to self administer erenumab via two 70 mg/mL autoinjector (AI)/pens on day 29 and day 57 of the CHU Sub-Study
Drug: Erenumab
Experimental
CHU Sub-Study: One 140 mg/mL AI/pen
A subset of participants in the OLTP randomized to self administer erenumab via one 140 mg/mL AI/pen on day 29 and day 57 of the CHU Sub-Study
Drug: Erenumab

Interventions

DrugPlacebo
placebo via subcutaneous injection
DrugErenumab
erenumab via subcutaneous injection
Also known as: AMG 334, Aimovig™
DrugErenumab
erenumab via autoinjector (AI)/pen
Also known as: AMG 334, Aimovig™

What researchers measure

Primary outcomes

Change From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6
A migraine day was defined as 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 a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: a) ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity; b) ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia. Change from baseline was calculated using the mean monthly migraine days from months 4, 5 and 6 of the DBTP minus the number of migraine days during the 4-week baseline phase. Least squares (LS) mean was estimated using a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (current, prior only, or no prior/current treatment), and baseline value as covariates.
Time frame: 4-week baseline phase and months 4, 5 and 6 of DBTP.
CHU Sub-Study: Participant-Reported Outcome of Attempted Full-Dose Administration at Day 29 (Week 4) and Day 57 (Week 8)
On CHU day 29 and day 57, site staff interviewed sub-study participants and asked if they administered a full, partial, or no dose of erenumab (after explaining that a full dose means that the entire volume of the AI/pen was injected) and documented the participant's response in the electronic case report form. Data presented are the percentage of participants who reported "full administration," "not full administration," or "discontinued investigational product (ie, no dose)." (Day 1 of the CHU substudy occurred at any OLTP study visit \[up to week 88\] as long as the participant had previously received at least 1 OL dose of erenumab 140 mg.)
Time frame: CHU day 29 (week 4) and day 57 (week 8)

Secondary outcomes

Percentage of Participants With at Least a 50% Reduction From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6
A migraine day was defined as 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 a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: a) ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity; b) ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia. At least a 50% reduction from baseline in monthly migraine days was determined if: (mean monthly migraine days over the last three months of the DBTP minus baseline monthly migraine days) \* 100 / baseline monthly migraine days, was less than or equal to -50%.
Time frame: 4-week baseline phase and months 4, 5 and 6 of DBTP.
Change From Baseline in Mean Monthly Acute Migraine-Specific Medication Treatment Days at Months 4, 5 and 6
An acute migraine-specific medication treatment day was defined as any calendar day during which the participant took a migraine-specific medication (ie, triptan or ergotamine-derivatives). The change from baseline was calculated using the mean monthly acute migraine-specific medication treatment days over the last three months (months 4, 5 and 6) of the DBTP minus the baseline monthly acute migraine-specific medication treatment days. LS mean was estimated using a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment), and baseline value as covariates.
Time frame: 4-week baseline phase and months 4, 5 and 6 of DBTP.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Discontinuations Due to TEAEs, and Fatal TEAEs During the DBTP
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious 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. Events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4= life-threatening, grade 5=death).
Time frame: From first dose of IP up to week 24
Number of Participants With TEAEs, Serious TEAEs, Discontinuations Due to TEAEs, and Fatal TEAEs During the OLTP
An AE is defined as any untoward medical occurrence in a clinical trial participant. An SAE is defined as an adverse event that meets at least 1 of the following serious 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. Events were graded according to the NCI CTCAE version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4= life-threatening, grade 5=death).
Time frame: From first dose of IP in the OLTP (week 24) through the end of the OLTP (week 100) plus 12 weeks
Number of Participants With TEAEs, Serious TEAEs, Discotninuations Due to TEAEs, Fatal TEAEs, and Adverse Device Effects During the CHU Sub-Study
An AE is defined as any untoward medical occurrence in a clinical trial participant. An SAE is defined as an adverse event that meets at least 1 of the following serious 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. Events were graded according to the NCI CTCAE version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4= life-threatening, grade 5=death). TEAEs leading to discontinuation of IP are TEAEs leading to complete discontinuation of erenumab regardless of CHU IP or parent study IP.
Time frame: CHU sub-study day 1 through day 85 (end of CHU sub-study). Day 1 of the CHU substudy occurred at any OLTP study visit (up to week 88) as long as the participant had previously received at least 1 OL dose of erenumab 140 mg.
Number of Participants With Post-Baseline Liver Function Test Abnormalities During the DBTP
Post-baseline is defined as any assessment done after the first dose of IP. Liver Function tests included alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBL). ULN=upper limit of normal.
Time frame: From the first dose of study IP through the end of the DBTP (up to week 24)
Number of Participants With Post-Baseline Liver Function Test Abnormalities During the OLTP
Post-baseline is defined as any assessment done after the first dose of OLTP IP. Liver Function tests included alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBL). ULN=upper limit of normal.
Time frame: From the first dose of OLTP IP (week 24) through the end of the OLTP (up to week 100)
Number of Participants With Blood Pressure Changes From Baseline in Categories at Week 24 During the DBTP
Participants with increases (↑) from baseline (BL) in diastolic blood pressure (DBP) and systolic blood pressure (SBP) at week 24 (Wk24) are presented.
Time frame: Baseline (last assessment prior to first dose of IP), week 24
Number of Participants With Blood Pressure Changes From Pre-OLTP Baseline in Categories at Week 100 During the OLTP
Participants with increases (↑) from baseline (BL) in diastolic blood pressure (DBP) and systolic blood pressure (SBP) at week 100 (Wk100) are presented.
Time frame: Pre-OLTP Baseline (last assessment prior to first dose of IP in OLTP), week 100
Number of Participants With Anti-Erenumab Antibodies During the Entire Study for Participants Who Received ≥ 1 Dose of Erenumab
Data are summarized by the treatment participants received during the double-blind treatment phase. Placebo participants may have received erenumab 70 mg or 140 mg during the OLTP. Baseline is defined as the last antibody assessment on or prior to the first dose of erenumab. Transient binding/neutralizing antibody responses are defined as a negative (neg) result at the participant's last timepoint tested among participants who developed binding/neutralizing antibodies post-baseline.
Time frame: Baseline (first dose of erenumab) up to end of study (week 100) plus 12 weeks

Results

Posted Mar 13, 2019

Participant flow

The study, initiated on 06 January 2016 at 43 centers in Japan, included a 24-week double-blind treatment phase (DBTP) followed by a 76-week open-label (OL) treatment phase (OLTP). DBTP: participants were randomized 2:1:2:2 to receive placebo, erenumab 28 mg, erenumab 70 mg, or erenumab 140 mg once monthly (QM) subcutaneously (SC).

Double-Blind Treatment Phase (DBTP)

Participant flow — Double-Blind Treatment Phase (DBTP)
Milestone	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM
Started	136	67	135	137
Received investigational product (ip)	136	66	135	137
Completed	133	65	130	134
Not completed	3	2	5	3
Withdrew: Protocol-specified criteria	0	1	0	2
Withdrew: Sponsor decision	0	0	1	0
Withdrew: Withdrawal by subject	2	1	4	1
Withdrew: Subject missed week 24 assessment	1	0	0	0

Open-Label Treatment Phase (OLTP)

Participant flow — Open-Label Treatment Phase (OLTP)
Milestone	OLTP: Erenumab 70 mg QM (Initial OL Dose)	OLTP: Erenumab 140 mg QM (Initial OL Dose)
Started	386	73
Received only 70 mg in oltp	270	0
Received only 140 mg in oltp	0	73
Received both 70 mg and 140 mg in oltp	116	0
Completed	357	69
Not completed	29	4
Withdrew: Protocol-specified criteria	4	1
Withdrew: Subject request	24	3
Withdrew: Decision by sponsor	1	0

Optional CHU Sub-Study (During OLTP)

Participant flow — Optional CHU Sub-Study (During OLTP)
Milestone	CHU Sub-Study: Two 70 mg/mL AI/Pens	CHU Sub-Study: One 140 mg/mL AI/Pen
Started	24	25
Completed	24	25
Not completed	0	0

Outcome measures

PrimaryChange From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6

A migraine day was defined as 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 a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: a) ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity; b) ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia. Change from baseline was calculated using the mean monthly migraine days from months 4, 5 and 6 of the DBTP minus the number of migraine days during the 4-week baseline phase. Least squares (LS) mean was estimated using a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (current, prior only, or no prior/current treatment), and baseline value as covariates.

Time frame:: 4-week baseline phase and months 4, 5 and 6 of DBTP.
Reported as:: Least squares mean · Days

Change From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6
Days	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM
Change From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6	0.06 (-0.46 to 0.58)	-1.19 (-1.91 to -0.47)	-2.25 (-2.78 to -1.73)	-1.83 (-2.35 to -1.31)

Statistical analysis

DBTP: Placebo vs DBTP: Erenumab 140 mg QM · Generalized Linear Mixed Model · p = <0.001 (P-values for pairwise comparisons were nominal and without multiplicity adjustment.) · Ls mean difference: -1.89 · 95% CI -2.58 to -1.20
DBTP: Placebo vs DPTP: Erenumab 70 mg QM · Generalized Linear Mixed Model · p = <0.001 (P-values for pairwise comparisons were nominal and without multiplicity adjustment.) · Ls mean difference: -2.31 · 95% CI -3.00 to -1.62
DBTP: Placebo vs DBTP: Erenumab 28 mg QM · Generalized Linear Mixed Model · p = 0.004 (P-values for pairwise comparisons were nominal and without multiplicity adjustment.) · Ls mean difference: -1.25 · 95% CI -2.10 to -0.41

PrimaryCHU Sub-Study: Participant-Reported Outcome of Attempted Full-Dose Administration at Day 29 (Week 4) and Day 57 (Week 8)

On CHU day 29 and day 57, site staff interviewed sub-study participants and asked if they administered a full, partial, or no dose of erenumab (after explaining that a full dose means that the entire volume of the AI/pen was injected) and documented the participant's response in the electronic case report form. Data presented are the percentage of participants who reported "full administration," "not full administration," or "discontinued investigational product (ie, no dose)." (Day 1 of the CHU substudy occurred at any OLTP study visit \[up to week 88\] as long as the participant had previously received at least 1 OL dose of erenumab 140 mg.)

Time frame:: CHU day 29 (week 4) and day 57 (week 8)
Reported as:: Number · percentage of participants

CHU Sub-Study: Participant-Reported Outcome of Attempted Full-Dose Administration at Day 29 (Week 4) and Day 57 (Week 8)
percentage of participants	CHU Sub-Study: Two 70 mg/mL AI/Pens	CHU Sub-Study: One 140 mg/mL AI/Pen
Week 4: Full Administration	100.0 (86.2 to 100.0)	100.0 (86.7 to 100.0)
Week 4: Not Full Administration	0.0 (0.0 to 13.8)	0.0 (0.0 to 13.3)
Week 4: Discontinued Investigational Product	0.0 (0.0 to 13.8)	0.0 (0.0 to 13.3)
Week 8: Full Administration	100.0 (86.2 to 100.0)	100.0 (86.7 to 100.0)
Week 8: Not Full Administration	0.0 (0.0 to 13.8)	0.0 (0.0 to 13.3)
Week 8: Discontinued Investigational Product	0.0 (0.0 to 13.8)	0.0 (0.0 to 13.3)

Statistical analysis

CHU Sub-Study: Two 70 mg/mL AI/Pens vs CHU Sub-Study: One 140 mg/mL AI/Pen · Treatment difference: 0.0 · 95% CI -13.3 to 13.8The 95% CI for the difference was calculated using the Newcombe hybrid score method.
CHU Sub-Study: Two 70 mg/mL AI/Pens vs CHU Sub-Study: One 140 mg/mL AI/Pen · Treatment difference: 0.0 · 95% CI -13.8 to 13.3The 95% CI for the difference was calculated using the Newcombe hybrid score method.
CHU Sub-Study: Two 70 mg/mL AI/Pens vs CHU Sub-Study: One 140 mg/mL AI/Pen · Treatment difference: 0.0 · 95% CI -13.8 to 13.3The 95% CI for the difference was calculated using the Newcombe hybrid score method.
CHU Sub-Study: Two 70 mg/mL AI/Pens vs CHU Sub-Study: One 140 mg/mL AI/Pen · Treatment difference: 0.0 · 95% CI -13.3 to 13.8The 95% CI for the difference was calculated using the Newcombe hybrid score method.
CHU Sub-Study: Two 70 mg/mL AI/Pens vs CHU Sub-Study: One 140 mg/mL AI/Pen · Treatment difference: 0.0 · 95% CI -13.8 to 13.3The 95% CI for the difference was calculated using the Newcombe hybrid score method.
CHU Sub-Study: Two 70 mg/mL AI/Pens vs CHU Sub-Study: One 140 mg/mL AI/Pen · Treatment difference: 0.0 · 95% CI -13.8 to 13.3The 95% CI for the difference was calculated using the Newcombe hybrid score method.

SecondaryPercentage of Participants With at Least a 50% Reduction From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6

A migraine day was defined as 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 a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: a) ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity; b) ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia. At least a 50% reduction from baseline in monthly migraine days was determined if: (mean monthly migraine days over the last three months of the DBTP minus baseline monthly migraine days) \* 100 / baseline monthly migraine days, was less than or equal to -50%.

Time frame:: 4-week baseline phase and months 4, 5 and 6 of DBTP.
Reported as:: Number · Percentage of participants

Percentage of Participants With at Least a 50% Reduction From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6
Percentage of participants	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM
Percentage of Participants With at Least a 50% Reduction From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6	7.4	19.7	28.9	27.2

Statistical analysis

DBTP: Placebo vs DBTP: Erenumab 140 mg QM · Cochran-Mantel-Haenszel · p = <0.001 (P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.) · Common odds ratio: 4.73 · 95% CI 2.24 to 9.99
DBTP: Placebo vs DPTP: Erenumab 70 mg QM · Cochran-Mantel-Haenszel · p = <0.001 (P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.) · Common odds ratio: 5.60 · 95% CI 2.60 to 12.06
DBTP: Placebo vs DBTP: Erenumab 28 mg QM · Cochran-Mantel-Haenszel · p = 0.009 (P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.) · Common odds ratio: 3.21 · 95% CI 1.30 to 7.88

SecondaryChange From Baseline in Mean Monthly Acute Migraine-Specific Medication Treatment Days at Months 4, 5 and 6

An acute migraine-specific medication treatment day was defined as any calendar day during which the participant took a migraine-specific medication (ie, triptan or ergotamine-derivatives). The change from baseline was calculated using the mean monthly acute migraine-specific medication treatment days over the last three months (months 4, 5 and 6) of the DBTP minus the baseline monthly acute migraine-specific medication treatment days. LS mean was estimated using a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment), and baseline value as covariates.

Time frame:: 4-week baseline phase and months 4, 5 and 6 of DBTP.
Reported as:: Least squares mean · Days

Change From Baseline in Mean Monthly Acute Migraine-Specific Medication Treatment Days at Months 4, 5 and 6
Days	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM
Change From Baseline in Mean Monthly Acute Migraine-Specific Medication Treatment Days at Months 4, 5 and 6	0.88 (0.44 to 1.33)	-0.19 (-0.80 to 0.43)	-1.19 (-1.64 to -0.74)	-1.16 (-1.60 to -0.71)

Statistical analysis

DBTP: Placebo vs DBTP: Erenumab 140 mg QM · Generalized Linear Mixed Model · p = <0.001 (P-values for pairwise comparisons were nominal and without multiplicity adjustment.) · Ls mean difference: -2.04 · 95% CI -2.63 to -1.45
DBTP: Placebo vs DPTP: Erenumab 70 mg QM · Generalized Linear Mixed Model · p = <0.001 (P-values for pairwise comparisons were nominal and without multiplicity adjustment.) · Ls mean difference: -2.07 · 95% CI -2.66 to -1.49
DBTP: Placebo vs DBTP: Erenumab 28 mg QM · Generalized Linear Mixed Model · p = 0.004 (P-values for pairwise comparisons were nominal and without multiplicity adjustment.) · Ls mean difference: -1.07 · 95% CI -1.80 to -0.35

SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Discontinuations Due to TEAEs, and Fatal TEAEs During the DBTP

An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious 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. Events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4= life-threatening, grade 5=death).

Time frame:: From first dose of IP up to week 24
Reported as:: Count of participants · Participants

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Discontinuations Due to TEAEs, and Fatal TEAEs During the DBTP
Participants	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM
All TEAEs	92	40	95	95
Grade ≥ 2 TEAEs	60	33	66	65
Grade ≥ 3 TEAEs	4	1	3	0
Grade ≥ 4 TEAEs	0	0	1	0
Serious TEAEs	4	1	1	1
TEAEs Leading to Discontinuation of IP	1	0	2	0
Fatal TEAEs	0	0	0	0

SecondaryNumber of Participants With TEAEs, Serious TEAEs, Discontinuations Due to TEAEs, and Fatal TEAEs During the OLTP

An AE is defined as any untoward medical occurrence in a clinical trial participant. An SAE is defined as an adverse event that meets at least 1 of the following serious 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. Events were graded according to the NCI CTCAE version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4= life-threatening, grade 5=death).

Time frame:: From first dose of IP in the OLTP (week 24) through the end of the OLTP (week 100) plus 12 weeks
Reported as:: Count of participants · Participants

Number of Participants With TEAEs, Serious TEAEs, Discontinuations Due to TEAEs, and Fatal TEAEs During the OLTP
Participants	OLTP: Erenumab 70 mg QM	OLTP: Erenumab 140 mg QM	OLTP: Total
All TEAEs	292	173	422
Grade ≥ 2 TEAEs	238	147	358
Grade ≥ 3 TEAEs	19	9	28
Grade ≥ 4 TEAEs	0	0	0
Serious TEAEs	18	9	27
TEAEs Leading to Discontinuation of IP	4	2	6
Fatal TEAEs	0	0	0

SecondaryNumber of Participants With TEAEs, Serious TEAEs, Discotninuations Due to TEAEs, Fatal TEAEs, and Adverse Device Effects During the CHU Sub-Study

Time frame:: CHU sub-study day 1 through day 85 (end of CHU sub-study). Day 1 of the CHU substudy occurred at any OLTP study visit (up to week 88) as long as the participant had previously received at least 1 OL dose of erenumab 140 mg.
Reported as:: Count of participants · Participants

Number of Participants With TEAEs, Serious TEAEs, Discotninuations Due to TEAEs, Fatal TEAEs, and Adverse Device Effects During the CHU Sub-Study
Participants	CHU Sub-Study: Two 70 mg/mL AI/Pens	CHU Sub-Study: One 140 mg/mL AI/Pen
All TEAEs	11	14
Grade ≥ 2 TEAEs	9	9
Grade ≥ 3 TEAEs	0	0
Grade ≥ 4 TEAEs	0	0
Serious TEAEs	1	0
TEAEs Leading to Discontinuation of IP	0	0
Fatal TEAEs	0	0
Adverse Device Effects	2	1

SecondaryNumber of Participants With Post-Baseline Liver Function Test Abnormalities During the DBTP

Post-baseline is defined as any assessment done after the first dose of IP. Liver Function tests included alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBL). ULN=upper limit of normal.

Time frame:: From the first dose of study IP through the end of the DBTP (up to week 24)
Reported as:: Count of participants · Participants

Number of Participants With Post-Baseline Liver Function Test Abnormalities During the DBTP
Participants	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM
Post-Baseline ALT or AST > 3 x ULN	0	0	3	1
Post-Baseline ALT or AST > 5 x ULN	0	0	0	1
Post-Baseline TBL > 1 x ULN	6	3	4	4
Post-Baseline TBL > 1.5 x ULN	0	1	0	1
Post-Baseline TBL > 2 x ULN	0	0	0	0
Post-Baseline ALP > 1.5 x ULN	0	0	0	0

SecondaryNumber of Participants With Post-Baseline Liver Function Test Abnormalities During the OLTP

Post-baseline is defined as any assessment done after the first dose of OLTP IP. Liver Function tests included alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBL). ULN=upper limit of normal.

Time frame:: From the first dose of OLTP IP (week 24) through the end of the OLTP (up to week 100)
Reported as:: Count of participants · Participants

Number of Participants With Post-Baseline Liver Function Test Abnormalities During the OLTP
Participants	OLTP: 70 mg SC QM (Only)	OLTP: 140 mg SC QM (Only)	OLTP: 70/140 mg SC QM (Both)	OLTP: Total
Post-Baseline ALT or AST > 3 x ULN	4	2	0	6
Post-Baseline ALT or AST > 5 x ULN	0	0	0	0
Post-Baseline TBL > 1 x ULN	12	3	6	21
Post-Baseline TBL > 1.5 x ULN	0	0	0	0
Post-Baseline TBL > 2 x ULN	0	0	0	0
Post-Baseline ALP > 1.5 x ULN	0	0	0	0

SecondaryNumber of Participants With Blood Pressure Changes From Baseline in Categories at Week 24 During the DBTP

Participants with increases (↑) from baseline (BL) in diastolic blood pressure (DBP) and systolic blood pressure (SBP) at week 24 (Wk24) are presented.

Time frame:: Baseline (last assessment prior to first dose of IP), week 24
Reported as:: Count of participants · Participants

Number of Participants With Blood Pressure Changes From Baseline in Categories at Week 24 During the DBTP
Participants	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM
↑ from BL ≥10 mmHg in DBP w/DBP >90 mmHg at Wk24	3	2	1	3
↑ from BL ≥10 mmHg in DBP w/DBP ≤90 mmHg at Wk24	14	6	14	8
↑ from BL ≥20 mmHg in SBP w/SBP >140 mmHg at Wk24	1	1	0	2
↑ from BL ≥20 mmHg in SBP w/SBP ≤140 mmHg at Wk24	0	2	0	3

SecondaryNumber of Participants With Blood Pressure Changes From Pre-OLTP Baseline in Categories at Week 100 During the OLTP

Participants with increases (↑) from baseline (BL) in diastolic blood pressure (DBP) and systolic blood pressure (SBP) at week 100 (Wk100) are presented.

Time frame:: Pre-OLTP Baseline (last assessment prior to first dose of IP in OLTP), week 100
Reported as:: Count of participants · Participants

Number of Participants With Blood Pressure Changes From Pre-OLTP Baseline in Categories at Week 100 During the OLTP
Participants	OLTP: 70 mg SC QM (Only)	OLTP: 140 mg SC QM (Only)	OLTP: 70/140 mg SC QM (Both)	OLTP: Total
↑ from BL ≥10 mmHg in DBP w/DBP >90 mmHg at Wk100	8	0	2	10
↑ from BL ≥10 mmHg in DBP w/DBP ≤90 mmHg at Wk100	25	10	10	45
↑ from BL ≥20 mmHg in SBP w/SBP >140 mmHg at Wk100	4	0	1	5
↑ from BL ≥20 mmHg in SBP w/SBP ≤140 mmHg at Wk100	7	2	0	9

SecondaryNumber of Participants With Anti-Erenumab Antibodies During the Entire Study for Participants Who Received ≥ 1 Dose of Erenumab

Data are summarized by the treatment participants received during the double-blind treatment phase. Placebo participants may have received erenumab 70 mg or 140 mg during the OLTP. Baseline is defined as the last antibody assessment on or prior to the first dose of erenumab. Transient binding/neutralizing antibody responses are defined as a negative (neg) result at the participant's last timepoint tested among participants who developed binding/neutralizing antibodies post-baseline.

Time frame:: Baseline (first dose of erenumab) up to end of study (week 100) plus 12 weeks
Reported as:: Count of participants · Participants

Number of Participants With Anti-Erenumab Antibodies During the Entire Study for Participants Who Received ≥ 1 Dose of Erenumab
Participants	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM
Binding Antibody Positive (BAb+) at Baseline (BL)	0	0	0
Neutralizing Antibody Positive (NAb+) at BL	0	0	0
BAb+ Post-BL With a Neg/No Result at BL	4	5	6
Transient BAb+ Post-BL With a Neg/No Result at BL	2	4	5
NAb+ Post-BL With a Neg/No Result at BL	0	0	0
Transient NAb+ Post-BL With a Neg/No Result at BL	0	0	0

Adverse events

Collected over All-cause mortality: from randomization through the end of study (up to 116 weeks). Treatment-emergent serious and non-serious events: - DBTP: from first dose of IP up to week 24 (end of DBTP) - OLTP: from first dose of OL IP (week 24) up to week 100 (end of OLTP) plus 12 weeks - CHU sub-study: from first dose of sub-study IP up to day 85 (end of sub-study). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
DBTP: Placebo	0/136 (0%)	4/136 (2.9%)	55/136 (40.4%)
DBTP: Erenumab 28 mg QM	0/67 (0%)	1/66 (1.5%)	28/66 (42.4%)
DPTP: Erenumab 70 mg QM	0/135 (0%)	1/135 (0.7%)	67/135 (49.6%)
DBTP: Erenumab 140 mg QM	0/137 (0%)	1/137 (0.7%)	58/137 (42.3%)
OLTP: Erenumab 70 mg QM	0/386 (0%)	18/386 (4.7%)	231/386 (59.8%)
OLTP: Erenumab 140 mg QM	0/189 (0%)	9/189 (4.8%)	133/189 (70.4%)
OLTP Total: Erenumab 70/140 mg QM	0/459 (0%)	27/459 (5.9%)	343/459 (74.7%)
CHU Sub-Study: Two Erenumab 70 mg/mL AI/Pens	0/24 (0%)	1/24 (4.2%)	7/24 (29.2%)
CHU Sub-Study: One Erenumab 140 mg/mL AI/Pen	0/25 (0%)	0/25 (0%)	7/25 (28%)
CHU Sub-Study Total	0/49 (0%)	1/49 (2%)	14/49 (28.6%)

Most frequent serious events

Showing 10 of 38

Most frequent serious events
Event	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM	OLTP: Erenumab 70 mg QM	OLTP: Erenumab 140 mg QM	OLTP Total: Erenumab 70/140 mg QM	CHU Sub-Study: Two Erenumab 70 mg/mL AI/Pens	CHU Sub-Study: One Erenumab 140 mg/mL AI/Pen	CHU Sub-Study Total
Mycobacterial infectionInfections and infestations	0/136	0/66	0/135	0/137	0/386	1/189	1/459	1/24	0/25	1/49
Hand fractureInjury, poisoning and procedural complications	0/136	1/66	0/135	0/137	0/386	1/189	1/459	0/24	0/25	0/49
Systemic lupus erythematosusMusculoskeletal and connective tissue disorders	0/136	0/66	1/135	0/137	0/386	0/189	0/459	0/24	0/25	0/49
Prinzmetal anginaCardiac disorders	1/136	0/66	0/135	0/137	0/386	0/189	0/459	0/24	0/25	0/49
HaemorrhoidsGastrointestinal disorders	1/136	0/66	0/135	0/137	1/386	0/189	1/459	0/24	0/25	0/49
Renal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/136	0/66	0/135	0/137	0/386	0/189	0/459	0/24	0/25	0/49
MigraineNervous system disorders	1/136	0/66	0/135	0/137	0/386	0/189	0/459	0/24	0/25	0/49
GastroenteritisInfections and infestations	0/136	0/66	0/135	1/137	0/386	0/189	0/459	0/24	0/25	0/49
Intestinal tuberculosisInfections and infestations	0/136	0/66	0/135	1/137	0/386	0/189	0/459	0/24	0/25	0/49
Vertigo positionalEar and labyrinth disorders	0/136	0/66	0/135	0/137	0/386	1/189	1/459	0/24	0/25	0/49

Most frequent other events

Most frequent other events
Event	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM	OLTP: Erenumab 70 mg QM	OLTP: Erenumab 140 mg QM	OLTP Total: Erenumab 70/140 mg QM	CHU Sub-Study: Two Erenumab 70 mg/mL AI/Pens	CHU Sub-Study: One Erenumab 140 mg/mL AI/Pen	CHU Sub-Study Total
NasopharyngitisInfections and infestations	41/136	22/66	39/135	45/137	174/386	109/189	274/459	5/24	6/25	11/49
InfluenzaInfections and infestations	4/136	1/66	3/135	1/137	46/386	29/189	75/459	1/24	0/25	1/49
GastroenteritisInfections and infestations	4/136	2/66	2/135	4/137	27/386	15/189	41/459	0/24	0/25	0/49
Back painMusculoskeletal and connective tissue disorders	2/136	3/66	7/135	1/137	28/386	7/189	34/459	1/24	0/25	1/49
PharyngitisInfections and infestations	3/136	3/66	5/135	3/137	22/386	7/189	28/459	1/24	0/25	1/49
Abdominal pain upperGastrointestinal disorders	1/136	1/66	5/135	2/137	22/386	4/189	26/459	0/24	1/25	1/49
Dental cariesGastrointestinal disorders	3/136	2/66	7/135	2/137	17/386	9/189	26/459	0/24	0/25	0/49
CystitisInfections and infestations	3/136	1/66	1/135	2/137	18/386	8/189	26/459	0/24	0/25	0/49
ConstipationGastrointestinal disorders	2/136	0/66	7/135	7/137	14/386	5/189	19/459	0/24	1/25	1/49

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM	Total
Mean	43.7 ± 9.1	42.8 ± 6.9	43.8 ± 9.0	45.0 ± 8.3	44.0 ± 8.6

Sex: Female, Male
Sex: Female, Male(Participants)	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM	Total
Female	118	55	115	112	400
Male	18	12	20	25	75

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM	Total
Hispanic or Latino	0	0	0	0	0
Not Hispanic or Latino	136	67	135	137	475
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	136	67	135	137	475
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	0	0	0	0
White	0	0	0	0	0
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Monthly Migraine Days at Baseline
Monthly Migraine Days at Baseline(Days)	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM	Total
Mean	7.67 ± 2.34	7.68 ± 2.14	7.84 ± 2.31	8.14 ± 2.43	7.86 ± 2.33

Treatment Status with Migraine Prophylactic Medication
Treatment Status with Migraine Prophylactic Medication(Participants)	DBTP: Placebo	DBTP: Erenumab 28 mg QM	DPTP: Erenumab 70 mg QM	DBTP: Erenumab 140 mg QM	Total
Current treatment	14	7	13	15	49
Prior treatment only	75	38	75	75	263
No prior or current treatment	47	22	47	47	163

Study locations

44 sites

Research Site
Kamogawa-shi, Chiba 296-0041, Japan
Research Site
Saijo-shi, Ehime 793-0030, Japan
Research Site
Ota-shi, Gunma 373-8585, Japan
Research Site
Hiroshima-shi, Hiroshima 730-8518, Japan
Research Site
Sapporo-shi, Hokkaido 060-0004, Japan
Research Site
Sapporo-shi, Hokkaido 060-8570, Japan
Research Site
Sapporo-shi, Hokkaido 063-0005, Japan
Research Site
Kobe-shi, Hyogo 658-0064, Japan
Research Site
Tsukuba-shi, Ibaraki 305-8576, Japan
Research Site
Kahoku-gun, Ishikawa 929-0342, Japan
Research Site
Morioka-shi, Iwate 020-8505, Japan
Research Site
Kagoshima-shi, Kagoshima 892-0844, Japan
Research Site
Kawasaki-shi, Kanagawa 211-8533, Japan
Research Site
Kawasaki-shi, Kanagawa 211-8588, Japan
Research Site
Kawasaki-shi, Kanagawa 216-8511, Japan
Research Site
Kumamoto-shi, Kumamoto 861-2101, Japan
Research Site
Kumamoto-shi, Kumamoto 862-8505, Japan
Research Site
Kyoto-shi, Kyoto 600-8811, Japan
Research Site
Sendai-shi, Miyagi 982-0014, Japan
Research Site
Osaka-shi, Osaka 556-0017, Japan
Research Site
Osakasayama-shi, Osaka 589-8511, Japan
Research Site
Toyonaka-shi, Osaka 560-0012, Japan
Research Site
Saga-shi, Saga 840-0806, Japan
Research Site
Iruma-gun, Saitama 350-0495, Japan
Research Site
Saitama-shi, Saitama 338-8577, Japan
Research Site
Tokorozawa-shi, Saitama 359-1141, Japan
Research Site
Shizuoka-shi, Shizuoka 420-0853, Japan
Research Site
Shimotsuga-gun, Tochigi 321-0293, Japan
Research Site
Bunkyo-ku, Tokyo 113-8431, Japan
Research Site
Bunkyo-ku, Tokyo 113-8603, Japan
Research Site
Chofu-shi, Tokyo 182-0006, Japan
Research Site
Chuo-ku, Tokyo 104-8560, Japan
Research Site
Hachioji-shi, Tokyo 192-0032, Japan
Research Site
Minato-ku, Tokyo 106-6106, Japan
Research Site
Minato-ku, Tokyo 108-8642, Japan
Research Site
Shibuya-ku, Tokyo 151-0051, Japan
Research Site
Shinjuku-ku, Tokyo 160-0017, Japan
Research Site
Shinjuku-ku, Tokyo 160-8582, Japan
Research Site
Yonago-city, Tottori 683-8504, Japan
Research Site
Toyama-shi, Toyama 930-0194, Japan
Research Site
Toyama-shi, Toyama 930-0803, Japan
Research Site
Hofu-shi, Yamaguchi 747-0802, Japan
Research Site
Yamaguchi-shi, Yamaguchi 754-0002, Japan
Research Site
Kai-shi, Yamanashi 400-0124, Japan

References and documents

Publications

Sakai F, Takeshima T, Tatsuoka Y, Hirata K, Lenz R, Wang Y, Cheng S, Hirama T, Mikol DD. A Randomized Phase 2 Study of Erenumab for the Prevention of Episodic Migraine in Japanese Adults. Headache. 2019 Nov;59(10):1731-1742. doi: 10.1111/head.13652. Epub 2019 Oct 14. PubMed 31612482 ↗
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. PubMed 35272533 ↗
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
Sakai F, Takeshima T, Tatsuoka Y, Hirata K, Cheng S, Numachi Y, Peng C, Xue F, Mikol DD. Long-term efficacy and safety during open-label erenumab treatment in Japanese patients with episodic migraine. Headache. 2021 Apr;61(4):653-661. doi: 10.1111/head.14096. Epub 2021 Mar 25. PubMed 33764538 ↗

Study documents

Study protocol · Jun 5, 2017
Statistical analysis plan · Feb 14, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting information: Study protocol, Sap, Icf, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02630459
Lead sponsor: Amgen
Responsible party: Sponsor
First posted: Dec 15, 2015
Start date: Jan 6, 2016
Primary completion: Sep 25, 2017
Completion: Jun 5, 2019
Results posted: Mar 13, 2019
Last update: Oct 12, 2022

Study contacts

study director · Amgen

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention

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