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

Migraine Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03867201
• Other study ID #: CAMG334A2304
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 26, 2019
• Est. completion date: June 28, 2024

Study information

• Verified date: March 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 557
• Est. completion date: June 28, 2024
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Biological:
• Erenumab
Administered by pre-filled syringe

Other:
• Placebo
Administered by pre-filled syringe

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Changchun	Jilin
China	Novartis Investigative Site	Changchun	Jilin
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Changsha City	Hunan
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Chongqing	Chongqing
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Guangzhou City	Guangdong
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Jinan	Shandong
China	Novartis Investigative Site	Jingzhou	Hubei
China	Novartis Investigative Site	Kunming City	Yunnan
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Qingdao	Shandong
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Shijiazhuang	Hebei
China	Novartis Investigative Site	Suzhou	Jiangsu
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Wuxi	Jiangsu
China	Novartis Investigative Site	XI An	Shanxi
China	Novartis Investigative Site	Xiamen	Fujian
China	Novartis Investigative Site	Yinchuan	Ningxia
China	Novartis Investigative Site	Zhengzhou	Henan
India	Novartis Investigative Site	DehraDun	Uttarakhand
India	Novartis Investigative Site	Lucknow	Uttar Pradesh
India	Novartis Investigative Site	Nashik	Maharashtra
Korea, Republic of	Novartis Investigative Site	Gyeonggi do
Korea, Republic of	Novartis Investigative Site	Hwaseong si	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Seoul	KOR
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Kuala Terengganu	Terengganu
Malaysia	Novartis Investigative Site	Seberang Jaya	Pulau Pinang
Malaysia	Novartis Investigative Site	Sungai Buloh	Selangor
Philippines	Novartis Investigative Site	Manila	Metro Manila
Philippines	Novartis Investigative Site	Pasig City
Singapore	Novartis Investigative Site	Singapore
Taiwan	Novartis Investigative Site	Chia-Yi
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taichung County
Taiwan	Novartis Investigative Site	Tainan
Taiwan	Novartis Investigative Site	Tainan
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taoyuan
Thailand	Novartis Investigative Site	Bangkok	THA
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai
Thailand	Novartis Investigative Site	Khon Kaen	THA
Vietnam	Novartis Investigative Site	Hanoi
Vietnam	Novartis Investigative Site	Ho Chi Minh	VNM

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

China,  India,  Korea, Republic of,  Malaysia,  Philippines,  Singapore,  Taiwan,  Thailand,  Vietnam, 

Outcome

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