MigrainePhase 3DRAGONNCT03867201

Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients

A Phase 3 study testing Erenumab in people with Migraine, run by Novartis Pharmaceuticals at 63 sites in 9 countries.

Completed

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

Trial summary

The purpose of this study was to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population. 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: 557 participants
Where: 63 sitesin 9 countries
Study dates: 26 Aug 2019to 30 Apr 2024
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 at least 5 attacks of migraine
≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period
>=80% diary compliance during the baseline period

Who cannot join

Older than 50 years of age at migraine onset
History of cluster or hemiplegic headache
Evidence of seizure or major psychiatric disorder
Cardiac or active hepatic disease
Pregnant or nursing

Trial locations and contacts

63 sites in 9 countries.

Country

City, postcode or hospital

63 sites in 9 countries

China30 sites

Novartis Investigative Site
Beijing, Beijing Municipality, 100000
Novartis Investigative Site
Beijing, Beijing Municipality, 100039
Novartis Investigative Site
Beijing, 065001
Novartis Investigative Site
Beijing, 100050
Novartis Investigative Site
Changchun, Jilin, 130021
Novartis Investigative Site
Changchun, Jilin, 130041
Novartis Investigative Site
Changsha, Hunan, 410003
Novartis Investigative Site
Changsha, Hunan, 410008
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Chongqing, 400016
Novartis Investigative Site
Guangzhou, Guangdong, 510000
Novartis Investigative Site
Hangzhou, Zhejiang, 310006
Novartis Investigative Site
Hangzhou, Zhejiang, 310016
Novartis Investigative Site
Jinan, Shandong, 250013
Novartis Investigative Site
Jingzhou, Hubei, 434020
Novartis Investigative Site
Kunming, Yunnan, 650000
Novartis Investigative Site
Nanjing, Jiangsu, 210008
Novartis Investigative Site
Nanjing, Jiangsu, 210029
Novartis Investigative Site
Qingdao, 266000
Novartis Investigative Site
Shanghai, 200040
Novartis Investigative Site
Shanghai, 200080
Novartis Investigative Site
Shenyang, Liaoning, 100016
Novartis Investigative Site
Shijiazhuang, Hebei, 500051
Novartis Investigative Site
Suzhou, Jiangsu, 215004
Novartis Investigative Site
Wuhan, Hubei, 430060
Novartis Investigative Site
Wuxi, Jiangsu, 214002
Novartis Investigative Site
Xiamen, Fujian, 361001
Novartis Investigative Site
Xian, Shanxi, 710061
Novartis Investigative Site
Yinchuan, Ningxia, 100039
Novartis Investigative Site
Zhengzhou, Henan, 450052

Other trials in China

Taiwan9 sites

Novartis Investigative Site
Chiayi City, 60002
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taichung County, 411743
Novartis Investigative Site
Tainan, 701
Novartis Investigative Site
Tainan, 71004
Novartis Investigative Site
Taipei, 10449
Novartis Investigative Site
Taipei, 11217
Novartis Investigative Site
Taipei, 114
Novartis Investigative Site
Taoyuan, 33305

Other trials in Taiwan

South Korea7 sites

Novartis Investigative Site
Gyeonggi-do, 11765
Novartis Investigative Site
Hwaseong-si, Gyeonggi-do, 18450
Novartis Investigative Site
Seoul, Korea, 08308
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03181
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 139-711

Other trials in South Korea

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

Malaysia4 sites

Novartis Investigative Site
Kuala Lumpur, 59100
Novartis Investigative Site
Kuala Terengganu, Terengganu, 20400
Novartis Investigative Site
Seberang Jaya, Pulau Pinang, 13700
Novartis Investigative Site
Sungai Buloh, Selangor, 47000

Other trials in Malaysia

India3 sites

Novartis Investigative Site
Dehradun, Uttarakhand, 248001
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226014
Novartis Investigative Site
Nashik, Maharashtra, 422005

Other trials in India

Philippines2 sites

Novartis Investigative Site
Manila, National Capital Region, 1000
Novartis Investigative Site
Pasig, 1605

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Vietnam2 sites

Novartis Investigative Site
Hanoi, 100000
Novartis Investigative Site
Ho Chi Minh City, VNM, 700000

Other trials in Vietnam

Singapore1 site

Novartis Investigative Site
Singapore, 169608

Other trials in Singapore

About this study

Official title: A 12-week Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Once Monthly Subcutaneous Erenumab 70 mg in Adult Chronic Migraine Patients

The purpose of this study was to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.

Read the detailed description

This study used a single-cohort, 2-treatment arms, randomized (1:1 (70 mg:placebo)), double-blind study design in adult subjects with chronic migraine. A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period to assess diary compliance and headache frequency.

Eligible patients were then randomized to either erenumab 70 mg or placebo for 12 weeks, followed by an open-label treatment period to last until end of PTA determined by the product launch in the country or the country's decision not to launch. A safety follow-up visit occurred 12 weeks after the last treatment for subjects who discontinue the double-blind treatment or who completed the double-blind treatment period without continuing in the open-label treatment period.

Conditions: Migraine
Being tested: Erenumab, Placebo
Keywords: AMG334, erenumab, migraine, chronic, headache, Chinese
Medical subject headings: Migraine Disorders, Bronchiolitis Obliterans Syndrome, Headache

What participants receive

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

ErenumabBiological
Also called AMG334
Administered by pre-filled syringe
PlaceboOther
Administered by pre-filled syringe

Study groups in NCT03867201
Study group	Role	What they receive
Erenumab	Experimental	Administered by pre-filled syringe Receives: Biological: Erenumab
Placebo	Placebo comparator	Administered by pre-filled syringe Receives: Other: Placebo

What is being measured

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

Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria:
1. ≥2 of the following pain features:
- Unilateral
- Throbbing
- Moderate to severe
- Exacerbated with exercise/physical activity
1. ≥1 of the following associated symptoms:
- Nausea and/or vomiting
- Photophobia and phonophobia
Measured: baseline (4 weeks period prior to start of study drug), week 9 to 12

Secondary outcomes (5)

Change From Baseline in Migraine-related Disability and Productivity as Measured by the mMIDAS During the Last 4 Weeks of the 12-week Treatment Period
The modified MIDAS is a 5-item self-administered questionnaire that sums the number of productive days lost over the past month in two settings: the workplace and the home. The MIDAS also assesses disability in family, social, and leisure activities. The MIDAS score is the sum of missed days due to a headache from paid work, housework, and non-work (family, social, leisure) activities; and days at paid work or housework where productivity was reduced by at least half.
Measured: baseline (4 weeks period prior to start of study drug), week 9 to 12
Number of Participants With at Least 50% Reduction From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria:
1. ≥2 of the following pain features:
- Unilateral
- Throbbing
- Moderate to severe
- Exacerbated with exercise/physical activity
1. ≥1 of the following associated symptoms:
- Nausea and/or vomiting
- Photophobia and phonophobia
Measured: baseline (4 weeks period prior to start of study drug), week 9 to 12
Change From Baseline in Monthly Acute Headache Medication Days During the Last 4 Weeks of the 12-week Treatment Period
An acute headache medication day was defined as a day when medication was taken to treat acute headache.
Measured: baseline (4 weeks period prior to start of study drug), week 9 to 12
Number of Subjects With Adverse Events as a Measure of Safety
Number of subjects with adverse events was assessed separately in the double-blind treatment period (DBTP) and the open-label treatment period (OLTP).
Measured: DBTP: 12 weeks for participants entering the OLTP. 20 weeks for participants NOT entering the OLTP. OLTP: From week 12 until up to approximately 4 years.
Number of Subjects With Anti-AMG 334 Antibodies
anti-AMG 334 antibodies assessed for binding and neutralizing)
Measured: baseline, 20 weeks

Timeline

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

26 Aug 201930 Apr 2024

First posted7 Mar 2019
Study start26 Aug 2019
Primary completion11 Aug 2021
Study completion30 Apr 2024

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 (2)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 557 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03867201
Sponsor's protocol ID: CAMG334A2304
Acronym: DRAGON
Status last verified: Oct 2025
First submitted: 25 Feb 2019
Last updated: 16 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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

Yu S, Kim BK, Wang H, Zhou J, Banerjee P, Lincy J, Reshetnyak E, Li Z, Leclair D, Wang SJ. Long-term safety and continued clinical benefit of erenumab 70 mg in Asian patients with chronic migraine: an open-label extension of the phase 3 DRAGON study. J Headache Pain. 2026 Jun 17. doi: 10.1186/s10194-026-02406-y. Online ahead of print.
PubMed 42310529
Yu S, Kim BK, Wang H, Zhou J, Wan Q, Yu T, Lian Y, Arkuszewski M, Ecochard L, Wen S, Yin F, Li Z, Su W, Wang SJ. A phase 3, randomised, placebo-controlled study of erenumab for the prevention of chronic migraine in patients from Asia: the DRAGON study. J Headache Pain. 2022 Nov 21;23(1):146. doi: 10.1186/s10194-022-01514-9.
PubMed 36404301

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

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
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Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-week Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Once Monthly Subcutaneous Erenumab 70 mg in Adult Chronic Migraine Patients
ClinicalTrials.gov ID: NCT03867201
Acronym / sponsor ID: DRAGON / CAMG334A2304
Conditions: Migraine
Keywords: AMG334, erenumab, migraine, chronic, headache, Chinese
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 557 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 26 Aug 2019 (actual)
Primary completion: 11 Aug 2021 (actual)
Study completion: 30 Apr 2024 (actual)
First posted: 7 Mar 2019 (actual)
Results: Posted 11 May 2025

Clinical summary

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

The purpose of this study was to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Erenumab	Experimental	Biological: ErenumabAdministered by pre-filled syringe
Placebo	Placebo comparator	Other: PlaceboAdministered by pre-filled syringe

Who may qualify

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

Key inclusion criteria (3 listed)

History of at least 5 attacks of migraine
≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period
>=80% diary compliance during the baseline period

Key exclusion criteria (5 listed)

Older than 50 years of age at migraine onset
History of cluster or hemiplegic headache
Evidence of seizure or major psychiatric disorder
Cardiac or active hepatic disease
Pregnant or nursing

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: AMG334Administered by pre-filled syringe	Biological	Erenumab
PlaceboAdministered by pre-filled syringe	Other	Placebo

Primary outcome

Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period
Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria: 1. ≥2 of the following pain features: * Unilateral * Throbbing * Moderate to severe * Exacerbated with exercise/physical activity 2. ≥1 of the following associated symptoms: * Nausea and/or vomiting * Photophobia and phonophobia

5 secondary outcomes

Change From Baseline in Migraine-related Disability and Productivity as Measured by the mMIDAS During the Last 4 Weeks of the 12-week Treatment Period
Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12
Number of Participants With at Least 50% Reduction From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period
Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12
Change From Baseline in Monthly Acute Headache Medication Days During the Last 4 Weeks of the 12-week Treatment Period
Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12
Number of Subjects With Adverse Events as a Measure of Safety
Time frame: DBTP: 12 weeks for participants entering the OLTP. 20 weeks for participants NOT entering the OLTP. OLTP: From week 12 until up to approximately 4 years.
Number of Subjects With Anti-AMG 334 Antibodies
Time frame: baseline, 20 weeks

Results and safety

Results posted to the registry on 11 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erenumab 70 mg	279	273
Placebo	278	272

Primary outcome: Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period

Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12. Least squares mean (Standard Error). Unit: days

Measure	Erenumab 70 mg n = 270	Placebo n = 274
Value	-8.19 (0.46)	-6.62 (0.45)

Erenumab 70 mg vs Placebo: Mean Difference (Net): -1.57 (95% CI -2.83 to -0.30), p = 0.015, Mixed Models Analysis

Population analysed: Full Analysis Set. All randomized participants with evaluable measurements at the respective timepoint.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Double-Blind Treatment Period: 12 weeks for participants entering the open-label treatment period. 20 weeks for participants NOT entering the open-label treatment period. Open-Label Treatment Period: From week 12 until up to approximately 4 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erenumab 70mg DBTP	7 of 279 (2.5%)	58 of 279 (20.8%)	0 of 279
Placebo DBTP	7 of 278 (2.5%)	59 of 278 (21.2%)	0 of 278
Erenumab 70mg OLTP (Erenumab 70mg in DBTP)	21 of 224 (9.4%)	92 of 224 (41.1%)	0 of 224
Erenumab 70mg OLTP (Placebo in DBTP)	24 of 232 (10.3%)	120 of 232 (51.7%)	0 of 232

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42310529Yu S, Kim BK, Wang H, Zhou J, Banerjee P, Lincy J, Reshetnyak E, Li Z, Leclair D, Wang SJ. Long-term safety and continued clinical benefit of erenumab 70 mg in Asian patients with chronic migraine: an open-label extension of the phase 3 DRAGON study. J Headache Pain. 2026 Jun 17. doi: 10.1186/s10194-026-02406-y. Online ahead of print.
Derived from this study: PubMed 36404301Yu S, Kim BK, Wang H, Zhou J, Wan Q, Yu T, Lian Y, Arkuszewski M, Ecochard L, Wen S, Yin F, Li Z, Su W, Wang SJ. A phase 3, randomised, placebo-controlled study of erenumab for the prevention of chronic migraine in patients from Asia: the DRAGON study. J Headache Pain. 2022 Nov 21;23(1):146. doi: 10.1186/s10194-022-01514-9.
A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
Individual participant dataSharing planned: 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

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
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Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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App-Based Migraine Treatment: The Health enSuite Study
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A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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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.

The record lists no contact. Use the official record to reach the sponsor.

63 sites in 9 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 Novartis Pharmaceuticals at 63 sites in 9 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 5 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 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in China, Taiwan, South Korea, Thailand, Malaysia and 4 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 11 May 2025). 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 During the Last 4 Weeks of the 12-week Treatment Period (time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12). 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 NCT03867201, which also lists 2 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 16 Oct 2025.