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Episodic MigrainePhase 3EMPOwERNCT03333109

Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients

A Phase 3 study testing Erenumab in people with Episodic Migraine, run by Novartis Pharmaceuticals at 81 sites in 11 countries.

Completed

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

Official record
Search all trials

Trial summary

This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Episodic 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
900 participants
Where
81 sitesin 11 countries
Study dates
8 Feb 2018to 13 Jan 2020
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

  • Documented history of migraine in the 12 months prior to screening
  • 4-14 days per month of migraine symptoms
  • >=80% diary compliance during the Baseline period

Who cannot join

  • >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

Trial locations and contacts

81 sites in 11 countries.

81 sites in 11 countries

India27 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 382428

  • Novartis Investigative Site

    Bangalore, Karnataka, 560054

  • Novartis Investigative Site

    Bangalore, Karnataka, 560060

  • Novartis Investigative Site

    Belagavi, 590010

  • Novartis Investigative Site

    Chennai, Tamil Nadu, 600100

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001

  • Novartis Investigative Site

    Guntur, Andhra Pradesh, 522 001

  • Novartis Investigative Site

    Hyderabad, Telangana, 500082

  • Novartis Investigative Site

    Kochi, Kerala, 682 026

  • Novartis Investigative Site

    Kochi, Kerala, 682027

  • Novartis Investigative Site

    Kolkata, West Bengal, 700017

  • Novartis Investigative Site

    Kolkata, West Bengal, 700068

  • Novartis Investigative Site

    Kozhikode, Kerala, 673004

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226014

  • Novartis Investigative Site

    Ludhiana, Punjab, 141001

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400008

  • Novartis Investigative Site

    Mumbai, Maharashtra, 401107

  • Novartis Investigative Site

    Mumbai, 400016

  • Novartis Investigative Site

    Mysore, Karnataka, 570001

  • Novartis Investigative Site

    Nagpur, Maharashtra, 400 012

  • Novartis Investigative Site

    Nashik, Maharashtra, 422 005

  • Novartis Investigative Site

    Nashik, Maharashtra, 422005

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110 060

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110002

  • Novartis Investigative Site

    New Delhi, 110029

  • Novartis Investigative Site

    Pune, Maharashtra, 411004

  • Novartis Investigative Site

    Thiruvananthapuram, Kerala, 695011

Other trials in India

South Korea12 sites

  • Novartis Investigative Site

    Busan, 47392

  • Novartis Investigative Site

    Daejeon, Korea, 35015

  • Novartis Investigative Site

    Gwangju, 61469

  • Novartis Investigative Site

    Gyeonggi-do, 11765

  • Novartis Investigative Site

    Hwaseong-si, Gyeonggi-do, 18450

  • Novartis Investigative Site

    Incheon, 22332

  • Novartis Investigative Site

    Seoul, Korea, 03080

  • Novartis Investigative Site

    Seoul, KOR, 03181

  • Novartis Investigative Site

    Seoul, KOR, 08308

  • Novartis Investigative Site

    Seoul, 03722

  • Novartis Investigative Site

    Seoul, 06351

  • Novartis Investigative Site

    Seoul, 139-711

Other trials in South Korea

Taiwan8 sites

  • Novartis Investigative Site

    Chiayi City, 60002

  • Novartis Investigative Site

    Taichung, 40447

  • Novartis Investigative Site

    Taichung County

  • Novartis Investigative Site

    Tainan, 71004

  • Novartis Investigative Site

    Tainan

  • Novartis Investigative Site

    Taipei, 10449

  • Novartis Investigative Site

    Taipei, 11217

  • Novartis Investigative Site

    Taoyuan, 33305

Other trials in Taiwan

Argentina7 sites

  • Novartis Investigative Site

    Buenos Aires, 1061

  • Novartis Investigative Site

    Buenos Aires, C1012AAR

  • Novartis Investigative Site

    CABA, Buenos Aires, C1056ABJ

  • Novartis Investigative Site

    CABA, Buenos Aires, C1181ACH

  • Novartis Investigative Site

    CABA, Buenos Aires, C1428AQK

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, C1128AAF

  • Novartis Investigative Site

    Córdoba, 5001

Other trials in Argentina

Lebanon5 sites

  • Novartis Investigative Site

    Beirut, 1107 2020

  • Novartis Investigative Site

    Beirut, 166378

  • Novartis Investigative Site

    Beirut, 6301

  • Novartis Investigative Site

    Beirut

  • Novartis Investigative Site

    El Chouf, LBN, 1503201002

Other trials in Lebanon

Malaysia5 sites

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586

  • Novartis Investigative Site

    Kuala Lumpur, MYS, 56000

  • Novartis Investigative Site

    Kuala Lumpur, 59100

  • Novartis Investigative Site

    Seberang Jaya, Pulau Pinang, 13700

  • Novartis Investigative Site

    Sungai Buloh, Selangor, 47000

Other trials in Malaysia

Thailand5 sites

  • Novartis Investigative Site

    Bangkok, THA, 10400

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

Other trials in Thailand

Mexico4 sites

  • Novartis Investigative Site

    Chihuahua City, 31203

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44130

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44610

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64060

Other trials in Mexico

Philippines4 sites

  • Novartis Investigative Site

    Manila, National Capital Region, 1000

  • Novartis Investigative Site

    Manila, National Capital Region, 1012

  • Novartis Investigative Site

    Pasig, 1605

  • Novartis Investigative Site

    Quezon City, 1102

Other trials in Philippines

Singapore2 sites

  • Novartis Investigative Site

    Singapore, 169608

  • Novartis Investigative Site

    Singapore, 308433

Other trials in Singapore

Vietnam2 sites

  • Novartis Investigative Site

    Hanoi, 100000

  • Novartis Investigative Site

    Ho Chi Minh City, VNM, 700000

Other trials in Vietnam

About this study

Official title: 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)

This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine

Read the detailed description

This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. The subjects were randomized to receive either erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period. After randomization/Day 1, visits occurred at four week intervals until Week 12, which was the End of Treatment. The final visit, Last Patient Last Visit was a Safety Follow-Up visit, which occurred 12 weeks later, at Week 24.

Being tested
Erenumab, Placebo
Keywords
AMG334, erenumab, episodic migraine, headache, CGRP, Calcitonin Gene-related, migraine, adult
Medical subject headings
Headache, Migraine Disorders

What participants receive

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

  • ErenumabBiological

    Also called AMG334

    70 mg/mL pre-filled syringe administered subcutaneously

  • PlaceboOther

    Matching placebo in pre-filled syringe administered subcutaneously

Study groups in NCT03333109
Study groupRoleWhat they receive
AMG334 70 mgExperimentalAMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
Receives: Biological: Erenumab
AMG334 140 mgExperimentalAMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
Receives: Biological: Erenumab
PlaceboPlacebo comparatorTwo pre-filled syringes containing placebo identical in appearance to erenumab
Receives: Other: Placebo

What is being measured

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

  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

    Measured: Baseline up to Month 3

Secondary outcomes (3)

  1. Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3

    Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3. 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

    Measured: Baseline and at Month 3

  2. Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3

    Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications include two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline is the number of migraine-specific medication treatment days in the baseline period.

    Measured: Baseline up to Month 3

  3. Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3

    The HIT-6 is a short-form self-administered questionnaire based on the internet-HIT question pool. The HIT-6 was developed as a global measure of adverse headache impact to assess headache severity in the previous month and change in a patient's clinical status over a short period of time. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social). Each of the 6 questions is responded to using 1 of 5 response categories: "never," "rarely," "sometimes," "very often," or "always." For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the response provided. These points were summed to produce a total HIT-6 score that ranges from 36 to 78. Scores were categorized into 4 grades, representing little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78) due to headache. Lower values represent better outcomes, therefore negative change denotes improveme

    Measured: Baseline up to Month 3

Timeline

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

  1. First posted6 Nov 2017
  2. Study start8 Feb 2018
  3. Primary completion13 Jan 2020
  4. Study completion13 Jan 2020

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03333109
Sponsor's protocol ID
CAMG334A2302
Acronym
EMPOwER
Status last verified
Oct 2021
First submitted
2 Nov 2017
Last updated
11 Oct 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 41641373

  • 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

  • Wang 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.

    PubMed 34171973

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erenumab in people with Episodic Migraine, run by Novartis Pharmaceuticals at 81 sites in 11 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 3 inclusion and 7 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 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in India, South Korea, Taiwan, Argentina, Lebanon and 6 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 9 Mar 2021). 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 Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP) (time frame: Baseline up to Month 3). 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 NCT03333109, which also lists 3 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 11 Oct 2021.

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