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

March 29, 2024 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 is to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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
      • Shanghai, China, 200080
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Novartis Investigative Site
    • Beijing
      • Beijing, Beijing, China, 100039
        • Novartis Investigative Site
      • Beijing, Beijing, China, 100000
        • Novartis Investigative Site
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Novartis Investigative Site
    • Fujian
      • Xiamen, Fujian, China, 361001
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Novartis Investigative Site
      • Guangzhou City, 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, 410003
        • Novartis Investigative Site
      • Changsha City, Hunan, China, 410011
        • 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
      • Qingdao, Shandong, China, 266003
        • Novartis Investigative Site
    • Shanxi
      • XI An, Shanxi, China, 710061
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Novartis Investigative Site
    • Yunnan
      • Kunming City, 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
  • Korea, Republic of
      • Gyeonggi do, Korea, Republic of, 11765
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 03080
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 03722
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 139-711
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 03181
        • Novartis Investigative Site
    • Gyeonggi Do
      • Hwaseong si, Gyeonggi Do, Korea, Republic of, 18450
        • Novartis Investigative Site
    • KOR
      • Seoul, KOR, Korea, Republic of, 08308
        • 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 City, Philippines, 1605
        • Novartis Investigative Site
    • Metro Manila
      • Manila, Metro Manila, Philippines, 1000
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
  • Taiwan
      • Chia-Yi, Taiwan, 60002
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taichung County, Taiwan, 411743
        • Novartis Investigative Site
      • Tainan, Taiwan, 71004
        • Novartis Investigative Site
      • Tainan, Taiwan, 701
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Taipei, Taiwan, 114
        • Novartis Investigative Site
      • Taipei, Taiwan, 10449
        • Novartis Investigative Site
      • Taoyuan, 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, 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
Time Frame
Change from baseline in monthly migraine days during the last 4 weeks of the 12-week treatment period
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
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: 12 weeks
12 weeks
Achievement of at least a 50% reduction from baseline in monthly migraine days during the last 4 weeks of the 12-week treatment period
Time Frame: 12 weeks
12 weeks
Change from baseline in monthly acute headache medication days during the last 4 weeks of the 12-week treatment period
Time Frame: 12 weeks
12 weeks
Number of subjects with adverse events as a measure of safety
Time Frame: through study completion, an average of 20 weeks
through study completion, an average of 20 weeks
Number of subjects with anti-AMG 334 antibodies (binding and if positive, neutralizing)
Time Frame: Day1, Week 12, Week 20
Day1, Week 12, Week 20

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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 (Estimated)

June 28, 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 (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

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.

Clinical Trials on Migraine

Clinical Trials on Erenumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe