Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients
DRAGON
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
1 other identifier
interventional
557
9 countries
63
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2019
Longer than P75 for phase_3
63 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
February 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedStudy Start
First participant enrolled
August 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedResults Posted
Study results publicly available
May 11, 2025
CompletedOctober 16, 2025
October 1, 2025
2 years
February 25, 2019
July 18, 2024
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 2. ≥1 of the following associated symptoms: * Nausea and/or vomiting * Photophobia and phonophobia
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
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
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
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
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
baseline, 20 weeks
Study Arms (2)
Erenumab
EXPERIMENTALAdministered by pre-filled syringe
Placebo
PLACEBO COMPARATORAdministered by pre-filled syringe
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Novartis Investigative Site
Beijing, Beijing Municipality, 100000, China
Novartis Investigative Site
Beijing, Beijing Municipality, 100039, China
Novartis Investigative Site
Xiamen, Fujian, 361001, China
Novartis Investigative Site
Guangzhou, Guangdong, 510000, China
Novartis Investigative Site
Shijiazhuang, Hebei, 500051, China
Novartis Investigative Site
Zhengzhou, Henan, 450052, China
Novartis Investigative Site
Jingzhou, Hubei, 434020, China
Novartis Investigative Site
Wuhan, Hubei, 430060, China
Novartis Investigative Site
Changsha, Hunan, 410003, China
Novartis Investigative Site
Changsha, Hunan, 410008, China
Novartis Investigative Site
Nanjing, Jiangsu, 210008, China
Novartis Investigative Site
Nanjing, Jiangsu, 210029, China
Novartis Investigative Site
Suzhou, Jiangsu, 215004, China
Novartis Investigative Site
Wuxi, Jiangsu, 214002, China
Novartis Investigative Site
Changchun, Jilin, 130021, China
Novartis Investigative Site
Changchun, Jilin, 130041, China
Novartis Investigative Site
Shenyang, Liaoning, 100016, China
Novartis Investigative Site
Yinchuan, Ningxia, 100039, China
Novartis Investigative Site
Jinan, Shandong, 250013, China
Novartis Investigative Site
Xian, Shanxi, 710061, China
Novartis Investigative Site
Chengdu, Sichuan, 610041, China
Novartis Investigative Site
Kunming, Yunnan, 650000, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310006, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310016, China
Novartis Investigative Site
Beijing, 065001, China
Novartis Investigative Site
Beijing, 100050, China
Novartis Investigative Site
Chongqing, 400016, China
Novartis Investigative Site
Qingdao, 266000, China
Novartis Investigative Site
Shanghai, 200040, China
Novartis Investigative Site
Shanghai, 200080, China
Novartis Investigative Site
Nashik, Maharashtra, 422005, India
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226014, India
Novartis Investigative Site
Dehradun, Uttarakhand, 248001, India
Novartis Investigative Site
Seberang Jaya, Pulau Pinang, 13700, Malaysia
Novartis Investigative Site
Sungai Buloh, Selangor, 47000, Malaysia
Novartis Investigative Site
Kuala Terengganu, Terengganu, 20400, Malaysia
Novartis Investigative Site
Kuala Lumpur, 59100, Malaysia
Novartis Investigative Site
Manila, National Capital Region, 1000, Philippines
Novartis Investigative Site
Pasig, 1605, Philippines
Novartis Investigative Site
Singapore, 169608, Singapore
Novartis Investigative Site
Hwaseong-si, Gyeonggi-do, 18450, South Korea
Novartis Investigative Site
Seoul, Korea, 08308, South Korea
Novartis Investigative Site
Gyeonggi-do, 11765, South Korea
Novartis Investigative Site
Seoul, 03080, South Korea
Novartis Investigative Site
Seoul, 03181, South Korea
Novartis Investigative Site
Seoul, 03722, South Korea
Novartis Investigative Site
Seoul, 139-711, South Korea
Novartis Investigative Site
Chiayi City, 60002, Taiwan
Novartis Investigative Site
Taichung, 40447, Taiwan
Novartis Investigative Site
Taichung County, 411743, Taiwan
Novartis Investigative Site
Tainan, 701, Taiwan
Novartis Investigative Site
Tainan, 71004, Taiwan
Novartis Investigative Site
Taipei, 10449, Taiwan
Novartis Investigative Site
Taipei, 11217, Taiwan
Novartis Investigative Site
Taipei, 114, Taiwan
Novartis Investigative Site
Taoyuan District, 33305, Taiwan
Novartis Investigative Site
Bangkok, THA, 10400, Thailand
Novartis Investigative Site
Khon Kaen, THA, 40002, Thailand
Novartis Investigative Site
Bangkok, 10330, Thailand
Novartis Investigative Site
Bangkok, 10400, Thailand
Novartis Investigative Site
Chiang Mai, 50200, Thailand
Novartis Investigative Site
Ho Chi Minh City, VNM, 700000, Vietnam
Novartis Investigative Site
Hanoi, 100000, Vietnam
Related Publications (1)
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.
PMID: 36404301DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- 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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2019
First Posted
March 7, 2019
Study Start
August 26, 2019
Primary Completion
August 11, 2021
Study Completion
April 30, 2024
Last Updated
October 16, 2025
Results First Posted
May 11, 2025
Record last verified: 2025-10
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