Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients (DRAGON)

October 8, 2025 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

557

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100050
        • Novartis Investigative Site
      • Beijing, China, 065001
        • Novartis Investigative Site
      • Chongqing, China, 400016
        • Novartis Investigative Site
      • Qingdao, China, 266000
        • Novartis Investigative Site
      • Shanghai, China, 200080
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Novartis Investigative Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Novartis Investigative Site
      • Beijing, Beijing Municipality, China, 100039
        • Novartis Investigative Site
    • Fujian
      • Xiamen, Fujian, China, 361001
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, China, 500051
        • Novartis Investigative Site
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Novartis Investigative Site
    • Hubei
      • Jingzhou, Hubei, China, 434020
        • Novartis Investigative Site
      • Wuhan, Hubei, China, 430060
        • Novartis Investigative Site
    • Hunan
      • Changsha, Hunan, China, 410008
        • Novartis Investigative Site
      • Changsha, Hunan, China, 410003
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Novartis Investigative Site
      • Nanjing, Jiangsu, China, 210008
        • Novartis Investigative Site
      • Suzhou, Jiangsu, China, 215004
        • Novartis Investigative Site
      • Wuxi, Jiangsu, China, 214002
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Novartis Investigative Site
      • Changchun, Jilin, China, 130041
        • Novartis Investigative Site
    • Liaoning
      • Shenyang, Liaoning, China, 100016
        • Novartis Investigative Site
    • Ningxia
      • Yinchuan, Ningxia, China, 100039
        • Novartis Investigative Site
    • Shandong
      • Jinan, Shandong, China, 250013
        • Novartis Investigative Site
    • Shanxi
      • Xian, Shanxi, China, 710061
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Novartis Investigative Site
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Novartis Investigative Site
      • Hangzhou, Zhejiang, China, 310006
        • Novartis Investigative Site
  • India
    • Maharashtra
      • Nashik, Maharashtra, India, 422005
        • Novartis Investigative Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • Novartis Investigative Site
    • Uttarakhand
      • Dehradun, Uttarakhand, India, 248001
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Novartis Investigative Site
    • Pulau Pinang
      • Seberang Jaya, Pulau Pinang, Malaysia, 13700
        • Novartis Investigative Site
    • Selangor
      • Sungai Buloh, Selangor, Malaysia, 47000
        • Novartis Investigative Site
    • Terengganu
      • Kuala Terengganu, Terengganu, Malaysia, 20400
        • Novartis Investigative Site
  • Philippines
      • Pasig, Philippines, 1605
        • Novartis Investigative Site
    • National Capital Region
      • Manila, National Capital Region, Philippines, 1000
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
  • South Korea
      • Gyeonggi-do, South Korea, 11765
        • Novartis Investigative Site
      • Seoul, South Korea, 03080
        • Novartis Investigative Site
      • Seoul, South Korea, 03722
        • Novartis Investigative Site
      • Seoul, South Korea, 03181
        • Novartis Investigative Site
      • Seoul, South Korea, 139-711
        • Novartis Investigative Site
    • Gyeonggi-do
      • Hwaseong-si, Gyeonggi-do, South Korea, 18450
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, South Korea, 08308
        • Novartis Investigative Site
  • Taiwan
      • Chiayi City, Taiwan, 60002
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taichung County, Taiwan, 411743
        • Novartis Investigative Site
      • Tainan City, Taiwan, 71004
        • Novartis Investigative Site
      • Tainan City, Taiwan, 701
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Taipei, Taiwan, 114
        • Novartis Investigative Site
      • Taipei, Taiwan, 10449
        • Novartis Investigative Site
      • Taoyuan District, Taiwan, 33305
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Novartis Investigative Site
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
    • THA
      • Bangkok, THA, Thailand, 10400
        • Novartis Investigative Site
      • Khon Kaen, THA, Thailand, 40002
        • Novartis Investigative Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Novartis Investigative Site
    • VNM
      • Ho Chi Minh City, VNM, Vietnam, 700000
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

key inclusion Criteria:

  1. History of at least 5 attacks of migraine
  2. ≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period
  3. >=80% diary compliance during the baseline period

Key exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erenumab
Administered by pre-filled syringe
Biological: Erenumab
Administered by pre-filled syringe
Other Names:
  • AMG334
Placebo Comparator: Placebo
Administered by pre-filled syringe
Other: Placebo
Administered by pre-filled syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline (4 weeks period prior to start of study drug), week 9 to 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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

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
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
An acute headache medication day was defined as a day when medication was taken to treat acute headache.
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 adverse events was assessed separately in the double-blind treatment period (DBTP) and the open-label treatment period (OLTP).
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
anti-AMG 334 antibodies assessed for binding and neutralizing)
baseline, 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Actual)

August 11, 2021

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Estimated)

October 16, 2025

Last Update Submitted That Met QC Criteria

October 8, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMG334A2304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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