Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
STRIVE
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
2 other identifiers
interventional
955
13 countries
129
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2015
129 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2015
CompletedFirst Posted
Study publicly available on registry
May 28, 2015
CompletedStudy Start
First participant enrolled
July 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2017
CompletedResults Posted
Study results publicly available
July 10, 2018
CompletedOctober 12, 2022
October 1, 2022
1.1 years
May 14, 2015
June 12, 2018
October 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
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
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
4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (129)
Research Site
Phoenix, Arizona, 85023, United States
Research Site
Anaheim, California, 92801, United States
Research Site
Encino, California, 91316, United States
Research Site
Irvine, California, 92618, United States
Research Site
Los Alamitos, California, 90720, United States
Research Site
Newport Beach, California, 92660, United States
Research Site
Rancho Mirage, California, 92270, United States
Research Site
Redlands, California, 92374, United States
Research Site
Sherman Oaks, California, 91403, United States
Research Site
Simi Valley, California, 93065, United States
Research Site
Spring Valley, California, 91978, United States
Research Site
Boulder, Colorado, 80301, United States
Research Site
East Hartford, Connecticut, 06118, United States
Research Site
Stamford, Connecticut, 06905, United States
Research Site
Waterbury, Connecticut, 06708, United States
Research Site
Bradenton, Florida, 34205, United States
Research Site
Jacksonville, Florida, 32256, United States
Research Site
Leesburg, Florida, 34748, United States
Research Site
Miami, Florida, 33135, United States
Research Site
Ocala, Florida, 34471, United States
Research Site
Orlando, Florida, 32801, United States
Research Site
Sunrise, Florida, 33351, United States
Research Site
West Palm Beach, Florida, 33407, United States
Research Site
Atlanta, Georgia, 30328, United States
Research Site
Boise, Idaho, 83704, United States
Research Site
Evansville, Indiana, 47714, United States
Research Site
Des Moines, Iowa, 50309, United States
Research Site
Newton, Kansas, 67114, United States
Research Site
Wichita, Kansas, 67207, United States
Research Site
Edgewood, Kentucky, 41017, United States
Research Site
Metairie, Louisiana, 70006, United States
Research Site
New Orleans, Louisiana, 70119, United States
Research Site
New Bedford, Massachusetts, 02740, United States
Research Site
Worcester, Massachusetts, 01605, United States
Research Site
Plymouth, Minnesota, 55441, United States
Research Site
Kansas City, Missouri, 64114, United States
Research Site
Springfield, Missouri, 65807, United States
Research Site
St Louis, Missouri, 63141, United States
Research Site
Amherst, New York, 14226, United States
Research Site
Plainview, New York, 11803, United States
Research Site
Rochester, New York, 14609, United States
Research Site
Durham, North Carolina, 27713, United States
Research Site
Greensboro, North Carolina, 27405, United States
Research Site
Cleveland, Ohio, 44122, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Willoughby Hills, Ohio, 44094, United States
Research Site
Portland, Oregon, 97210, United States
Research Site
Philadelphia, Pennsylvania, 19107, United States
Research Site
Cumberland, Rhode Island, 02864, United States
Research Site
Port Royal, South Carolina, 29935, United States
Research Site
Memphis, Tennessee, 38119, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Austin, Texas, 78731, United States
Research Site
Bedford, Texas, 76022, United States
Research Site
Irving, Texas, 75039, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Salt Lake City, Utah, 84109, United States
Research Site
West Jordan, Utah, 84088, United States
Research Site
Charlottesville, Virginia, 22911, United States
Research Site
Innsbruck, 6020, Austria
Research Site
Linz, 4020, Austria
Research Site
Vienna, 1090, Austria
Research Site
Vienna, 1130, Austria
Research Site
Brussels, 1090, Belgium
Research Site
Ghent, 9000, Belgium
Research Site
Hasselt, 3500, Belgium
Research Site
Liège, 4000, Belgium
Research Site
Lodelinsart, 6042, Belgium
Research Site
Surrey, British Columbia, V3Z 2N6, Canada
Research Site
Hamilton, Ontario, L8N 1Y2, Canada
Research Site
Markham, Ontario, L3R 9X3, Canada
Research Site
Ottawa, Ontario, K2G 6E2, Canada
Research Site
Lévis, Quebec, G6W 0M5, Canada
Research Site
Brno, 656 91, Czechia
Research Site
Hradec Králové, 500 05, Czechia
Research Site
Olomouc, 775 20, Czechia
Research Site
Pardubice, 530 02, Czechia
Research Site
Prague, 120 00, Czechia
Research Site
Prague, 140 59, Czechia
Research Site
Helsinki, 00100, Finland
Research Site
Kuopio, 70210, Finland
Research Site
Oulu, 90220, Finland
Research Site
Turku, 20100, Finland
Research Site
Berlin, 10117, Germany
Research Site
Berlin, 10435, Germany
Research Site
Bochum, 44787, Germany
Research Site
Cologne, 50935, Germany
Research Site
Frankfurt am Main, 60596, Germany
Research Site
Hamburg, 20249, Germany
Research Site
Hamburg, 20251, Germany
Research Site
Hellersdorf, 12627, Germany
Research Site
Hüttenberg, 35652, Germany
Research Site
Kiel, 24149, Germany
Research Site
Leipzig, 04103, Germany
Research Site
Leipzig, 04107, Germany
Research Site
München, 81377, Germany
Research Site
Wiesbaden, 65191, Germany
Research Site
Würzburg, 97080, Germany
Research Site
Leiden, 2333 ZA, Netherlands
Research Site
Krakow, 31-505, Poland
Research Site
Lodz, 90-338, Poland
Research Site
Lublin, 20-016, Poland
Research Site
Poznan, 60-355, Poland
Research Site
Świdnik, 21-040, Poland
Research Site
Warsaw, 02-097, Poland
Research Site
Bratislava, 833 05, Slovakia
Research Site
Komárno, 945 75, Slovakia
Research Site
Lučenec, 984 39, Slovakia
Research Site
Falköping, 521 37, Sweden
Research Site
Helsingborg, 252 21, Sweden
Research Site
Stockholm, 112 45, Sweden
Research Site
Stockholm, 114 33, Sweden
Research Site
Uddevalla, 451 50, Sweden
Research Site
Adana, 1330, Turkey (Türkiye)
Research Site
Ankara, 06500, Turkey (Türkiye)
Research Site
Antalya, 07058, Turkey (Türkiye)
Research Site
Bursa, 16059, Turkey (Türkiye)
Research Site
Istanbul, 34098, Turkey (Türkiye)
Research Site
Istanbul, 34384, Turkey (Türkiye)
Research Site
Izmir, 35040, Turkey (Türkiye)
Research Site
Izmir, 35340, Turkey (Türkiye)
Research Site
Glasgow, G51 4TF, United Kingdom
Research Site
Liverpool, L9 7AL, United Kingdom
Research Site
London, RM1 3PJ, United Kingdom
Research Site
London, SE5 9RS, United Kingdom
Research Site
Northwood, HA6 2RN, United Kingdom
Research Site
Oxford, OX3 9DU, United Kingdom
Research Site
Sidcup, DA14 6LT, United Kingdom
Research Site
Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (17)
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.
PMID: 30086681BACKGROUNDCheng 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.
BACKGROUNDGoadsby 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.
PMID: 29171821BACKGROUNDZhou 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.
PMID: 35272533BACKGROUNDKawata 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.
PMID: 35137394BACKGROUNDMcAllister 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.
PMID: 34841526BACKGROUNDAshina 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.
PMID: 31707815BACKGROUNDKudrow 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.
PMID: 31852816BACKGROUNDLipton 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.
PMID: 34407654BACKGROUNDYucel 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.
PMID: 33315334BACKGROUNDLampl 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.
PMID: 35978286DERIVEDAshina 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.
PMID: 34928306DERIVEDTepper 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.
PMID: 34301173DERIVEDDiener 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.
PMID: 33939497DERIVEDBroessner 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.
PMID: 32851644DERIVEDPavlovic JM, Paemeleire K, Gobel H, Bonner J, Rapoport A, Kagan R, Zhang F, Picard H, Mikol DD. Efficacy and safety of erenumab in women with a history of menstrual migraine. J Headache Pain. 2020 Aug 3;21(1):95. doi: 10.1186/s10194-020-01167-6.
PMID: 32746775DERIVEDGoadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Wright IK, Chou DE, Klatt J, Picard H, Lenz RA, Mikol DD. One-year sustained efficacy of erenumab in episodic migraine: Results of the STRIVE study. Neurology. 2020 Aug 4;95(5):e469-e479. doi: 10.1212/WNL.0000000000010019. Epub 2020 Jul 7.
PMID: 32636324DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2015
First Posted
May 28, 2015
Study Start
July 17, 2015
Primary Completion
September 5, 2016
Study Completion
June 19, 2017
Last Updated
October 12, 2022
Results First Posted
July 10, 2018
Record last verified: 2022-10