Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
EMPOwER
A 12-week Double-blind, Randomized, Multi-center Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients (EMPOwER)
1 other identifier
interventional
900
11 countries
81
Brief Summary
This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2018
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedStudy Start
First participant enrolled
February 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2020
CompletedResults Posted
Study results publicly available
March 9, 2021
CompletedOctober 11, 2021
October 1, 2021
1.9 years
November 2, 2017
January 11, 2021
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP)
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity 2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia
Baseline up to Month 3
Secondary Outcomes (3)
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3
Baseline and at Month 3
Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3
Baseline up to Month 3
Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3
Baseline up to Month 3
Study Arms (3)
AMG334 70 mg
EXPERIMENTALAMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
AMG334 140 mg
EXPERIMENTALAMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
Placebo
PLACEBO COMPARATORTwo pre-filled syringes containing placebo identical in appearance to erenumab
Interventions
Eligibility Criteria
You may qualify if:
- Documented history of migraine in the 12 months prior to screening
- days per month of migraine symptoms
- \>=80% diary compliance during the Baseline period
You may not qualify if:
- \>50 years old at migraine onset
- Pregnant or nursing
- History of cluster or hemiplegic headache
- Evidence of seizure or major psychiatric disorder
- Score of 19 or higher on the BDI
- Active chronic pain syndrome
- Cardiac or hepatic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Novartis Investigative Site
CABA, Buenos Aires, C1056ABJ, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1181ACH, Argentina
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CABA, Buenos Aires, C1428AQK, Argentina
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Buenos Aires, 1061, Argentina
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Buenos Aires, C1012AAR, Argentina
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Ciudad Autonoma de Bs As, C1128AAF, Argentina
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CĂ³rdoba, 5001, Argentina
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Guntur, Andhra Pradesh, 522 001, India
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Ahmedabad, Gujarat, 382428, India
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Bangalore, Karnataka, 560054, India
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Bangalore, Karnataka, 560060, India
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Mysore, Karnataka, 570001, India
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Kochi, Kerala, 682 026, India
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Kochi, Kerala, 682027, India
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Kozhikode, Kerala, 673004, India
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Thiruvananthapuram, Kerala, 695011, India
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Mumbai, Maharashtra, 400008, India
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Mumbai, Maharashtra, 401107, India
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Nagpur, Maharashtra, 400 012, India
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Nashik, Maharashtra, 422 005, India
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Nashik, Maharashtra, 422005, India
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Pune, Maharashtra, 411004, India
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New Delhi, National Capital Territory of Delhi, 110 060, India
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New Delhi, National Capital Territory of Delhi, 110002, India
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Ludhiana, Punjab, 141001, India
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Chennai, Tamil Nadu, 600100, India
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Hyderabad, Telangana, 500082, India
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Lucknow, Uttar Pradesh, 226014, India
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Dehradun, Uttarakhand, 248001, India
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Kolkata, West Bengal, 700017, India
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Kolkata, West Bengal, 700068, India
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Belagavi, 590010, India
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Mumbai, 400016, India
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New Delhi, 110029, India
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El Chouf, LBN, 1503201002, Lebanon
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Beirut, 1107 2020, Lebanon
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Beirut, 166378, Lebanon
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Beirut, 6301, Lebanon
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Beirut, Lebanon
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Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, MYS, 56000, Malaysia
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Seberang Jaya, Pulau Pinang, 13700, Malaysia
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Sungai Buloh, Selangor, 47000, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Guadalajara, Jalisco, 44130, Mexico
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Guadalajara, Jalisco, 44610, Mexico
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Monterrey, Nuevo LeĂ³n, 64060, Mexico
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Chihuahua City, 31203, Mexico
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Manila, National Capital Region, 1000, Philippines
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Manila, National Capital Region, 1012, Philippines
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Pasig, 1605, Philippines
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Quezon City, 1102, Philippines
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Singapore, 169608, Singapore
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Singapore, 308433, Singapore
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Hwaseong-si, Gyeonggi-do, 18450, South Korea
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Daejeon, Korea, 35015, South Korea
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Seoul, Korea, 03080, South Korea
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Seoul, KOR, 03181, South Korea
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Seoul, KOR, 08308, South Korea
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Busan, 47392, South Korea
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Gwangju, 61469, South Korea
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Gyeonggi-do, 11765, South Korea
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Incheon, 22332, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Seoul, 139-711, South Korea
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Chiayi City, 60002, Taiwan
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Taichung, 40447, Taiwan
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Taichung County, Taiwan
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Tainan, 71004, Taiwan
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Tainan, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan District, 33305, Taiwan
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Bangkok, THA, 10400, Thailand
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Khon Kaen, THA, 40002, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Ho Chi Minh City, VNM, 700000, Vietnam
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Hanoi, 100000, Vietnam
Related Publications (3)
Wang SJ, Roxas AA, Saravia B, Kim BK, Chowdhury D, Riachi NJ, Tai MS, Tanprawate S, Tran TN, Zhao YJ, Su W, Wen S, Mondal S, Ecochard L, Arkuszewski M. Effect of Erenumab on Patient-Reported Outcomes in Episodic Migraine in Asia, the Middle East, and Latin America: Results From the EMPOwER Study. Neurol Clin Pract. 2026 Apr;16(2):e200565. doi: 10.1212/CPJ.0000000000200565. Epub 2026 Feb 2.
PMID: 41641373DERIVEDLampl 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: 35978286DERIVEDWang SJ, Roxas AA Jr, Saravia B, Kim BK, Chowdhury D, Riachi N, Tai MS, Tanprawate S, Ngoc TT, Zhao YJ, Mikol DD, Pandhi S, Wen S, Mondal S, Tenenbaum N, Hours-Zesiger P. Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study. Cephalalgia. 2021 Nov;41(13):1285-1297. doi: 10.1177/03331024211024160. Epub 2021 Jun 25.
PMID: 34171973DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
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
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2017
First Posted
November 6, 2017
Study Start
February 8, 2018
Primary Completion
January 13, 2020
Study Completion
January 13, 2020
Last Updated
October 11, 2021
Results First Posted
March 9, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com