search
Back to results

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

Primary Purpose

Migraine

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Erenumab
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring AMG334, erenumab, migraine, chronic, headache, Chinese

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Erenumab

Placebo

Arm Description

Administered by pre-filled syringe

Administered by pre-filled syringe

Outcomes

Primary Outcome Measures

Change from baseline in monthly migraine days during the last 4 weeks of the 12-week treatment period

Secondary Outcome Measures

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
Achievement of at least a 50% reduction from baseline in monthly migraine days during the last 4 weeks of the 12-week treatment period
Change from baseline in monthly acute headache medication days during the last 4 weeks of the 12-week treatment period
Number of subjects with adverse events as a measure of safety
Number of subjects with anti-AMG 334 antibodies (binding and if positive, neutralizing)

Full Information

First Posted
February 25, 2019
Last Updated
October 13, 2023
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT03867201
Brief Title
Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients
Acronym
DRAGON
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
August 11, 2021 (Actual)
Study Completion Date
June 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
AMG334, erenumab, migraine, chronic, headache, Chinese

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
557 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erenumab
Arm Type
Experimental
Arm Description
Administered by pre-filled syringe
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered by pre-filled syringe
Intervention Type
Biological
Intervention Name(s)
Erenumab
Other Intervention Name(s)
AMG334
Intervention Description
Administered by pre-filled syringe
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Administered by pre-filled syringe
Primary Outcome Measure Information:
Title
Change from baseline in monthly migraine days during the last 4 weeks of the 12-week treatment period
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Change from baseline in monthly acute headache medication days during the last 4 weeks of the 12-week treatment period
Time Frame
12 weeks
Title
Number of subjects with adverse events as a measure of safety
Time Frame
through study completion, an average of 20 weeks
Title
Number of subjects with anti-AMG 334 antibodies (binding and if positive, neutralizing)
Time Frame
Day1, Week 12, Week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
key inclusion Criteria: 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: 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
Facility Information:
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
065001
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Novartis Investigative Site
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Novartis Investigative Site
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361001
Country
China
Facility Name
Novartis Investigative Site
City
Guangzhou City
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Novartis Investigative Site
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
500051
Country
China
Facility Name
Novartis Investigative Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Novartis Investigative Site
City
Jingzhou
State/Province
Hubei
ZIP/Postal Code
434020
Country
China
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Novartis Investigative Site
City
Changsha City
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Novartis Investigative Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410003
Country
China
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Novartis Investigative Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Novartis Investigative Site
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214002
Country
China
Facility Name
Novartis Investigative Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Novartis Investigative Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
Novartis Investigative Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
100016
Country
China
Facility Name
Novartis Investigative Site
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
100039
Country
China
Facility Name
Novartis Investigative Site
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Novartis Investigative Site
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Facility Name
Novartis Investigative Site
City
XI An
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Novartis Investigative Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Novartis Investigative Site
City
Kunming City
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Novartis Investigative Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Facility Name
Novartis Investigative Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226014
Country
India
Facility Name
Novartis Investigative Site
City
DehraDun
State/Province
Uttarakhand
ZIP/Postal Code
248001
Country
India
Facility Name
Novartis Investigative Site
City
Hwaseong si
State/Province
Gyeonggi Do
ZIP/Postal Code
18450
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
KOR
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
KOR
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Gyeonggi do
ZIP/Postal Code
11765
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
139-711
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seberang Jaya
State/Province
Pulau Pinang
ZIP/Postal Code
13700
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Sungai Buloh
State/Province
Selangor
ZIP/Postal Code
47000
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Kuala Terengganu
State/Province
Terengganu
ZIP/Postal Code
20400
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Manila
State/Province
Metro Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Novartis Investigative Site
City
Pasig City
ZIP/Postal Code
1605
Country
Philippines
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Novartis Investigative Site
City
Chia-Yi
ZIP/Postal Code
60002
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taichung County
ZIP/Postal Code
411743
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Bangkok
State/Province
THA
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novartis Investigative Site
City
Khon Kaen
State/Province
THA
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novartis Investigative Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Novartis Investigative Site
City
Ho Chi Minh
State/Province
VNM
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Novartis Investigative Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

We'll reach out to this number within 24 hrs