MigrainePhase 3STRIVENCT02456740

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention

A Phase 3 study testing Erenumab in people with Migraine, run by Amgen at 129 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine
What is being tested?: Erenumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 955 participants
Where: 129 sitesin 13 countries
Study dates: 17 Jul 2015to 19 Jun 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

History of migraine (with or without aura) for ≥ 12 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3) classification
Migraine frequency: ≥ 4 and < 15 migraine days per month on average across the 3 months prior to screening and during baseline
Headache frequency: < 15 headache days per month on average across the 3 months prior to screening and baseline
Demonstrated at least 80% compliance with the eDiary.

Who cannot join

Older than 50 years of age at migraine onset
History of cluster headache or hemiplegic migraine headache
Unable to differentiate migraine from other headache
No therapeutic response with > 2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial
Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase
Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study

Trial locations and contacts

129 sites in 13 countries.

Country

City, postcode or hospital

129 sites in 13 countries

United States59 sites

Research Site
Amherst, New York, 14226
Research Site
Anaheim, California, 92801
Research Site
Atlanta, Georgia, 30328
Research Site
Austin, Texas, 78731
Research Site
Bedford, Texas, 76022
Research Site
Boise, Idaho, 83704
Research Site
Boulder, Colorado, 80301
Research Site
Bradenton, Florida, 34205
Research Site
Charlottesville, Virginia, 22911
Research Site
Cleveland, Ohio, 44122
Research Site
Cleveland, Ohio, 44195
Research Site
Cumberland, Rhode Island, 02864
Research Site
Des Moines, Iowa, 50309
Research Site
Durham, North Carolina, 27713
Research Site
East Hartford, Connecticut, 06118
Research Site
Edgewood, Kentucky, 41017
Research Site
Encino, California, 91316
Research Site
Evansville, Indiana, 47714
Research Site
Greensboro, North Carolina, 27405
Research Site
Irvine, California, 92618
Research Site
Irving, Texas, 75039
Research Site
Jacksonville, Florida, 32256
Research Site
Kansas City, Missouri, 64114
Research Site
Leesburg, Florida, 34748
Research Site
Los Alamitos, California, 90720
Research Site
Memphis, Tennessee, 38119
Research Site
Metairie, Louisiana, 70006
Research Site
Miami, Florida, 33135
Research Site
Nashville, Tennessee, 37203
Research Site
New Bedford, Massachusetts, 02740
Research Site
New Orleans, Louisiana, 70119
Research Site
Newport Beach, California, 92660
Research Site
Newton, Kansas, 67114
Research Site
Ocala, Florida, 34471
Research Site
Orlando, Florida, 32801
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Phoenix, Arizona, 85023
Research Site
Plainview, New York, 11803
Research Site
Plymouth, Minnesota, 55441
Research Site
Port Royal, South Carolina, 29935
Research Site
Portland, Oregon, 97210
Research Site
Rancho Mirage, California, 92270
Research Site
Redlands, California, 92374
Research Site
Rochester, New York, 14609
Research Site
Salt Lake City, Utah, 84109
Research Site
San Antonio, Texas, 78229
Research Site
Sherman Oaks, California, 91403
Research Site
Simi Valley, California, 93065
Research Site
Spring Valley, California, 91978
Research Site
Springfield, Missouri, 65807
Research Site
St Louis, Missouri, 63141
Research Site
Stamford, Connecticut, 06905
Research Site
Sunrise, Florida, 33351
Research Site
Waterbury, Connecticut, 06708
Research Site
West Jordan, Utah, 84088
Research Site
West Palm Beach, Florida, 33407
Research Site
Wichita, Kansas, 67207
Research Site
Willoughby Hills, Ohio, 44094
Research Site
Worcester, Massachusetts, 01605

Other trials in United States

Germany15 sites

Research Site
Berlin, 10117
Research Site
Berlin, 10435
Research Site
Bochum, 44787
Research Site
Cologne, 50935
Research Site
Frankfurt am Main, 60596
Research Site
Hamburg, 20249
Research Site
Hamburg, 20251
Research Site
Hellersdorf, 12627
Research Site
Hüttenberg, 35652
Research Site
Kiel, 24149
Research Site
Leipzig, 04103
Research Site
Leipzig, 04107
Research Site
München, 81377
Research Site
Wiesbaden, 65191
Research Site
Würzburg, 97080

Other trials in Germany

Turkey (Türkiye)8 sites

Research Site
Adana, 1330
Research Site
Ankara, 06500
Research Site
Antalya, 07058
Research Site
Bursa, 16059
Research Site
Istanbul, 34098
Research Site
Istanbul, 34384
Research Site
Izmir, 35040
Research Site
Izmir, 35340

Other trials in Turkey (Türkiye)

United Kingdom8 sites

Research Site
Glasgow, G51 4TF
Research Site
Liverpool, L9 7AL
Research Site
London, RM1 3PJ
Research Site
London, SE5 9RS
Research Site
Northwood, HA6 2RN
Research Site
Oxford, OX3 9DU
Research Site
Sidcup, DA14 6LT
Research Site
Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Czechia6 sites

Research Site
Brno, 656 91
Research Site
Hradec Králové, 500 05
Research Site
Olomouc, 775 20
Research Site
Pardubice, 530 02
Research Site
Prague, 120 00
Research Site
Prague, 140 59

Other trials in Czechia

Poland6 sites

Research Site
Krakow, 31-505
Research Site
Lodz, 90-338
Research Site
Lublin, 20-016
Research Site
Poznan, 60-355
Research Site
Świdnik, 21-040
Research Site
Warsaw, 02-097

Other trials in Poland

Belgium5 sites

Research Site
Brussels, 1090
Research Site
Ghent, 9000
Research Site
Hasselt, 3500
Research Site
Liège, 4000
Research Site
Lodelinsart, 6042

Other trials in Belgium

Canada5 sites

Research Site
Hamilton, Ontario, L8N 1Y2
Research Site
Lévis, Quebec, G6W 0M5
Research Site
Markham, Ontario, L3R 9X3
Research Site
Ottawa, Ontario, K2G 6E2
Research Site
Surrey, British Columbia, V3Z 2N6

Other trials in Canada

Sweden5 sites

Research Site
Falköping, 521 37
Research Site
Helsingborg, 252 21
Research Site
Stockholm, 112 45
Research Site
Stockholm, 114 33
Research Site
Uddevalla, 451 50

Other trials in Sweden

Austria4 sites

Research Site
Innsbruck, 6020
Research Site
Linz, 4020
Research Site
Vienna, 1090
Research Site
Vienna, 1130

Other trials in Austria

Finland4 sites

Research Site
Helsinki, 00100
Research Site
Kuopio, 70210
Research Site
Oulu, 90220
Research Site
Turku, 20100

Other trials in Finland

Slovakia3 sites

Research Site
Bratislava, 833 05
Research Site
Komárno, 945 75
Research Site
Lučenec, 984 39

Other trials in Slovakia

Netherlands1 site

Research Site
Leiden, 2333 ZA

Other trials in Netherlands

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days.

Read the detailed description

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. The trial consisted of four phases: screening (≤ 3 weeks of initial screening and a 4-week baseline phase); the double-blind treatment phase (24 weeks) in which participants received placebo or erenumab 70 mg or 140 mg daily; the active-treatment phase, in which participants underwent repeat randomization and were assigned to receive 70 mg or 140 mg of erenumab (28 weeks); and a safety follow-up phase (12 weeks).

Conditions: Migraine
Being tested: Erenumab, Placebo
Keywords: Migraine, Headache, Prevention, Prophylaxis
Medical subject headings: Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ErenumabDrug
Also called AMG 334, Aimovig™
Administered by subcutaneous injection once a month
PlaceboDrug
Administered by subcutaneous injection once a month

Study groups in NCT02456740
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received placebo once a month (QM) by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded. Receives: Drug: Placebo
Erenumab 70 mg QM	Experimental	Participants received erenumab 70 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded. Receives: Drug: Erenumab
Erenumab 140 mg QM	Experimental	Participants received erenumab 140 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded. Receives: Drug: Erenumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.
The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.
Measured: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

Secondary outcomes (4)

Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days in the Last 3 Months of the Double-blind Treatment Phase
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.
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 3 months (mean of months 4, 5 and 6) of the 24-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.
Measured: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase
Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days to the Last 3 Months of the Double-blind Treatment Period
Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.
The change from baseline in monthly acute migraine-specific treatment days was calculated as the average number of migraine-specific treatment days per month during the last 3 months of the 24-week double-blind treatment phase - the number of migraine-specific treatment days during the 4-week baseline phase.
Measured: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase
Change From Baseline in Mean Monthly Average Physical Impairment Domain Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase
The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from "Without any difficulty" (1) to "Unable to do" (5) and frequency items ranging from "None of the time" (1) to "All of the time" (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 - 100, with higher scores representing greater impact of migraine.
Change from baseline was calculated as (mean monthly average physical impairment scores as measured by the MPFID over the last 3 months of the double-blind treatment period) - (baseline monthly average physical impairment scores as measured by the MPFID).
Measured: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase
Change From Baseline in Mean Monthly Average Impact on Everyday Activities Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase
The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from "Without any difficulty" (1) to "Unable to do" (5) and frequency items ranging from "None of the time" (1) to "All of the time" (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 - 100, with higher scores representing greater impact of migraine.
Change from baseline was calculated as (mean monthly impact on everyday activities scores as measured by the MPFID over the last 3 months of the double-blind treatment period) - (baseline monthly impact on everyday activities scores as measured by the MPFID).
Measured: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 201519 Jun 2017

First posted28 May 2015 (estimated)
Study start17 Jul 2015
Primary completion5 Sep 2016
Study completion19 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 955 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02456740
Sponsor's protocol ID: 20120296
Other IDs: 2014-004464-38, 2014
Acronym: STRIVE
Status last verified: Oct 2022
First submitted: 14 May 2015
Last updated: 12 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Buse DC, Lipton RB, Hallstrom Y, Reuter U, Tepper SJ, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab. Cephalalgia. 2018 Sep;38(10):1622-1631. doi: 10.1177/0333102418789072. Epub 2018 Aug 7.
PubMed 30086681
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.
Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.
PubMed 29171821
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
Kawata AK, Ladd MK, Lipton RB, Buse DC, Bensink M, Shah S, Hareendran A, Mannix S, Mikol D. Reducing the physical, social, and emotional impact of episodic migraine: Results from erenumab STRIVE and ARISE phase III randomized trials. Headache. 2022 Feb;62(2):159-168. doi: 10.1111/head.14258. Epub 2022 Feb 8.
PubMed 35137394
McAllister PJ, Turner I, Reuter U, Wang A, Scanlon J, Klatt J, Chou DE, Paiva da Silva Lima G. Timing and durability of response to erenumab in patients with episodic migraine. Headache. 2021 Nov;61(10):1553-1561. doi: 10.1111/head.14233. Epub 2021 Nov 28.
PubMed 34841526
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.
PubMed 31707815
Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18.
PubMed 31852816
Lipton RB, Dodick DW, Kudrow D, Reuter U, Tenenbaum N, Zhang F, Lima GPDS, Chou DE, Mikol DD. Reduction in migraine pain intensity in patients treated with erenumab: A post hoc analysis of two pivotal randomized studies. Cephalalgia. 2021 Dec;41(14):1458-1466. doi: 10.1177/03331024211028966. Epub 2021 Aug 18.
PubMed 34407654
Yucel A, Thach A, Kumar S, Loden C, Bensink M, Goldfarb N. Estimating the economic burden of migraine on US employers. Am J Manag Care. 2020 Dec 1;26(12):e403-e408. doi: 10.37765/ajmc.2020.88547.
PubMed 33315334
Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.
PubMed 35978286
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.
PubMed 34928306
Tepper SJ, Ashina M, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Picard H, Cheng S, Chou DE, Zhang F, Klatt J, Mikol DD. Reduction in acute migraine-specific and non-specific medication use in patients treated with erenumab: post-hoc analyses of episodic and chronic migraine clinical trials. J Headache Pain. 2021 Jul 23;22(1):81. doi: 10.1186/s10194-021-01292-w.
PubMed 34301173
Diener HC, Ashina M, Ritter S, Paiva Da Silva Lima G, Rasmussen S, Zielman R, Tfelt-Hansen P. Erenumab prevents the occurrence of migraine attacks and not just migraine days: Post-hoc analyses of a phase III study. Cephalalgia. 2021 Oct;41(11-12):1262-1267. doi: 10.1177/03331024211010308. Epub 2021 May 3.
PubMed 33939497
Broessner G, Reuter U, Bonner JH, Dodick DW, Hallstrom Y, Picard H, Zhang F, Lenz RA, Klatt J, Mikol DD. The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving >/=50%, >/=75%, and 100% Response. Headache. 2020 Oct;60(9):2026-2040. doi: 10.1111/head.13929. Epub 2020 Aug 26.
PubMed 32851644

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
ClinicalTrials.gov ID: NCT02456740
Acronym / sponsor ID: STRIVE / 20120296
Conditions: Migraine
Keywords: Migraine, Headache, Prevention, Prophylaxis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 955 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 17 Jul 2015 (actual)
Primary completion: 5 Sep 2016 (actual)
Study completion: 19 Jun 2017 (actual)
First posted: 28 May 2015 (estimated)
Results: Posted 10 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo once a month (QM) by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.
Erenumab 70 mg QM	Experimental	Drug: ErenumabParticipants received erenumab 70 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.
Erenumab 140 mg QM	Experimental	Drug: ErenumabParticipants received erenumab 140 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

History of migraine (with or without aura) for ≥ 12 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3) classification
Migraine frequency: ≥ 4 and < 15 migraine days per month on average across the 3 months prior to screening and during baseline
Headache frequency: < 15 headache days per month on average across the 3 months prior to screening and baseline
Demonstrated at least 80% compliance with the eDiary.

Key exclusion criteria (6 listed)

Older than 50 years of age at migraine onset
History of cluster headache or hemiplegic migraine headache
Unable to differentiate migraine from other headache
No therapeutic response with > 2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial
Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ErenumabAlso: AMG 334, Aimovig™Administered by subcutaneous injection once a month	Drug	Erenumab 140 mg QM, Erenumab 70 mg QM
PlaceboAdministered by subcutaneous injection once a month	Drug	Placebo

Primary outcome

Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period
Time frame: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.

4 secondary outcomes

Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days in the Last 3 Months of the Double-blind Treatment Phase
Time frame: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase
Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days to the Last 3 Months of the Double-blind Treatment Period
Time frame: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase
Change From Baseline in Mean Monthly Average Physical Impairment Domain Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase
Time frame: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase
Change From Baseline in Mean Monthly Average Impact on Everyday Activities Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase
Time frame: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

Results and safety

Results posted to the registry on 10 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	319	282
Erenumab 70 mg QM	317	284
Erenumab 140 mg QM	319	292
Placebo / Erenumab 70 mg	0	0
Erenumab 70 mg / Erenumab 70 mg	0	0
Erenumab 140 mg / Erenumab 70 mg	0	0
Placebo / Erenumab 140 mg	0	0
Erenumab 70 mg / Erenumab 140 mg	0	0
Erenumab 140 mg / Erenumab 140 mg	0	0

Primary outcome: Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period

Time frame: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase. Least squares mean (Standard Error). Unit: migraine days / month

Measure	Placebo n = 316	Erenumab 70 mg QM n = 312	Erenumab 140 mg QM n = 318
Value	-1.83 (0.18)	-3.23 (0.18)	-3.67 (0.18)

Placebo vs Erenumab 70 mg QM: LS Mean Difference: -1.40 (95% CI -1.88 to -0.92), p < 0.001, Generalized Linear Mixed Model
Placebo vs Erenumab 140 mg QM: LS Mean Difference: -1.85 (95% CI -2.33 to -1.37), p < 0.001, Generalized Linear Mixed Model

Population analysed: The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly migraine days in the double-blind treatment phase.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug up to 16 weeks after the last dose. The double-blind treatment phase was 24 weeks and the open-label treatment phase was 28 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-blind Treatment Phase: Placebo	7 of 319 (2.2%)	53 of 319 (16.6%)	Not reported
Double-blind Treatment Phase: Erenumab 70 mg	8 of 314 (2.5%)	53 of 314 (16.9%)	Not reported
Double-blind Treatment Phase: Erenumab 140 mg	8 of 319 (2.5%)	54 of 319 (16.9%)	Not reported
Active Treatment Phase: Erenumab 70 mg	14 of 421 (3.3%)	83 of 421 (19.7%)	Not reported
Active Treatment Phase: Erenumab 140 mg	14 of 424 (3.3%)	63 of 424 (14.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30086681Buse DC, Lipton RB, Hallstrom Y, Reuter U, Tepper SJ, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab. Cephalalgia. 2018 Sep;38(10):1622-1631. doi: 10.1177/0333102418789072. Epub 2018 Aug 7.
BackgroundCheng 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.
Background: PubMed 29171821Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.
Background: PubMed 35272533Zhou 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.
Background: PubMed 35137394Kawata AK, Ladd MK, Lipton RB, Buse DC, Bensink M, Shah S, Hareendran A, Mannix S, Mikol D. Reducing the physical, social, and emotional impact of episodic migraine: Results from erenumab STRIVE and ARISE phase III randomized trials. Headache. 2022 Feb;62(2):159-168. doi: 10.1111/head.14258. Epub 2022 Feb 8.
Background: PubMed 34841526McAllister PJ, Turner I, Reuter U, Wang A, Scanlon J, Klatt J, Chou DE, Paiva da Silva Lima G. Timing and durability of response to erenumab in patients with episodic migraine. Headache. 2021 Nov;61(10):1553-1561. doi: 10.1111/head.14233. Epub 2021 Nov 28.
Background: PubMed 31707815Ashina 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.
Background: PubMed 31852816Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18.
Background: PubMed 34407654Lipton RB, Dodick DW, Kudrow D, Reuter U, Tenenbaum N, Zhang F, Lima GPDS, Chou DE, Mikol DD. Reduction in migraine pain intensity in patients treated with erenumab: A post hoc analysis of two pivotal randomized studies. Cephalalgia. 2021 Dec;41(14):1458-1466. doi: 10.1177/03331024211028966. Epub 2021 Aug 18.
Background: PubMed 33315334Yucel A, Thach A, Kumar S, Loden C, Bensink M, Goldfarb N. Estimating the economic burden of migraine on US employers. Am J Manag Care. 2020 Dec 1;26(12):e403-e408. doi: 10.37765/ajmc.2020.88547.
Derived from this study: PubMed 35978286Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.
Derived from this study: PubMed 34928306Ashina 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

129 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erenumab in people with Migraine, run by Amgen at 129 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Germany, Turkey (Türkiye), United Kingdom, Czechia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period (time frame: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02456740, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.