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

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

ClinicalTrials.gov Identifier: NCT03867201

Novartis Reference Number: CAMG334A2304

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Migraine
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
550 participants
Start date 
Aug 26, 2019
Completion date 
Jan 24, 2022
Gender 
All
Age(s)
18 Years - 65 Years (Adult, Older Adult)

Interventions

Biological
Erenumab
Administered by pre-filled syringe
Other
Placebo
Administered by pre-filled syringe

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

Study Locations

China
Novartis Investigative Site
Recruiting
Beijing, 100000
Beijing
China
Novartis Investigative Site
Recruiting
Beijing, 100039
Beijing
China
Novartis Investigative Site
Recruiting
Beijing,
Beijing
China
Novartis Investigative Site
Recruiting
Chongqing, 400016
Chongqing
China
Novartis Investigative Site
Recruiting
Xiamen, 361001
Fujian
China
Novartis Investigative Site
Recruiting
Guangzhou City, 510000
Guangdong
China
Novartis Investigative Site
Recruiting
Guangzhou, 510000
Guangdong
China
Novartis Investigative Site
Recruiting
Shijiazhuang, 500051
Hebei
China
Novartis Investigative Site
Recruiting
Zhengzhou, 450052
Henan
China
Novartis Investigative Site
Recruiting
Jingzhou,
Hubei
China
Novartis Investigative Site
Recruiting
Wuhan, 430060
Hubei
China
Novartis Investigative Site
Recruiting
Changsha City, 410011
Hunan
China
Novartis Investigative Site
Recruiting
Changsha, 410003
Hunan
China
Novartis Investigative Site
Recruiting
Nanjing, 210008
Jiangsu
China
Novartis Investigative Site
Recruiting
Nanjing, 210029
Jiangsu
China
Novartis Investigative Site
Recruiting
Suzhou, 215004
Jiangsu
China
Novartis Investigative Site
Recruiting
Wuxi,
Jiangsu
China
Novartis Investigative Site
Recruiting
Changchun, 130021
Jilin
China
Novartis Investigative Site
Recruiting
Changchun, 130041
Jilin
China
Novartis Investigative Site
Recruiting
Shenyang, 100016
Liaoning
China
Novartis Investigative Site
Recruiting
Yinchuan, 100039
Ningxia
China
Novartis Investigative Site
Recruiting
Jinan, 250013
Shandong
China
Novartis Investigative Site
Recruiting
Qingdao, 266003
Shandong
China
Novartis Investigative Site
Recruiting
XI An, 710061
Shanxi
China
Novartis Investigative Site
Recruiting
Chengdu, 610041
Sichuan
China
Novartis Investigative Site
Recruiting
Kunming City, 650000
Yunnan
China
Novartis Investigative Site
Recruiting
Hangzhou, 310006
Zhejiang
China
Novartis Investigative Site
Recruiting
Hangzhou, 310016
Zhejiang
China
Novartis Investigative Site
Recruiting
Beijing, 100050
-
China
Novartis Investigative Site
Recruiting
Beijing, 100730
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200040
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200080
-
China
India
Novartis Investigative Site
Recruiting
Nashik, 422005
Maharashtra
India
Novartis Investigative Site
Recruiting
DehraDun, 248001
Uttarakhand
India
Korea, Republic of
Novartis Investigative Site
Recruiting
Hwaseong si, 18450
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03181
KOR
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 08308
KOR
Korea, Republic of
Novartis Investigative Site
Recruiting
Gyeonggi do, 11765
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03722
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 139-711
-
Korea, Republic of
Malaysia
Novartis Investigative Site
Recruiting
Seberang Jaya, 13700
Pulau Pinang
Malaysia
Novartis Investigative Site
Recruiting
Sungai Buloh, 47000
Selangor
Malaysia
Novartis Investigative Site
Recruiting
Kuala Terengganu, 20400
Terengganu
Malaysia
Novartis Investigative Site
Recruiting
Kuala Lumpur, 59100
-
Malaysia
Philippines
Novartis Investigative Site
Recruiting
Manila, 1000
Metro Manila
Philippines
Novartis Investigative Site
Recruiting
Pasig City, 1605
-
Philippines
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119260
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169608
-
Singapore
Taiwan
Novartis Investigative Site
Recruiting
Chia-Yi, 60002
-
Taiwan
Novartis Investigative Site
Recruiting
Taichung County,
-
Taiwan
Novartis Investigative Site
Recruiting
Taichung, 40447
-
Taiwan
Novartis Investigative Site
Recruiting
Tainan, 71004
-
Taiwan
Novartis Investigative Site
Recruiting
Tainan,
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10449
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 11217
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 114
-
Taiwan
Novartis Investigative Site
Recruiting
Taoyuan, 33305
-
Taiwan
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10400
THA
Thailand
Novartis Investigative Site
Recruiting
Khon Kaen, 40002
THA
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10330
-
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10400
-
Thailand
Novartis Investigative Site
Recruiting
Chiang Mai, 50200
-
Thailand
Vietnam
Novartis Investigative Site
Recruiting
Ho Chi Minh, 700000
VNM
Vietnam

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]