Clinical trial NCT03867201: Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: AMG334
erenumab
migraine
chronic
headache
Chinese
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2019-03-07
Enrollment: 557
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period
timeFrame: baseline (4 weeks period prior to start of study drug), week 9 to 12
Secondary outcomes:
measure: 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
timeFrame: baseline (4 weeks period prior to start of study drug), week 9 to 12
measure: 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
timeFrame: baseline (4 weeks period prior to start of study drug), week 9 to 12
measure: Change From Baseline in Monthly Acute Headache Medication Days During the Last 4 Weeks of the 12-week Treatment Period
timeFrame: baseline (4 weeks period prior to start of study drug), week 9 to 12
measure: Number of Subjects With Adverse Events as a Measure of Safety
timeFrame: 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.
measure: Number of Subjects With Anti-AMG 334 Antibodies
timeFrame: baseline, 20 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Xiamen
country: China
facility: Novartis Investigative Site
state: Fujian
city: Guangzhou City
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Shijiazhuang
country: China
facility: Novartis Investigative Site
state: Hebei
city: Zhengzhou
country: China
facility: Novartis Investigative Site
state: Henan
city: Jingzhou
country: China
facility: Novartis Investigative Site
state: Hubei
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Suzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Wuxi
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Chang Chun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Changchun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Yinchuan
country: China
facility: Novartis Investigative Site
state: Ningxia
city: Jinan
country: China
facility: Novartis Investigative Site
state: Shandong
city: Xian
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Kunming City
country: China
facility: Novartis Investigative Site
state: Yunnan
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Qingdao
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Lucknow
country: India
facility: Novartis Investigative Site
state: Uttar Pradesh
city: Dehradun
country: India
facility: Novartis Investigative Site
state: Uttarakhand
city: Hwaseong si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Gyeonggi do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seberang Jaya
country: Malaysia
facility: Novartis Investigative Site
state: Pulau Pinang
city: Sungai Buloh
country: Malaysia
facility: Novartis Investigative Site
state: Selangor
city: Kuala Terengganu
country: Malaysia
facility: Novartis Investigative Site
state: Terengganu
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Manila
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Pasig City
country: Philippines
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Chia-Yi
country: Taiwan
facility: Novartis Investigative Site
city: Taichung County
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taoyuan
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Ho Chi Minh
country: Vietnam
facility: Novartis Investigative Site
state: VNM
city: Hanoi
country: Vietnam
facility: Novartis Investigative Site
Study officials:
References: