The purpose of this study was to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
557
Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria: 1. ≥2 of the following pain features: * Unilateral * Throbbing * Moderate to severe * Exacerbated with exercise/physical activity 2. ≥1 of the following associated symptoms: * Nausea and/or vomiting * Photophobia and phonophobia
Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12
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
The modified MIDAS is a 5-item self-administered questionnaire that sums the number of productive days lost over the past month in two settings: the workplace and the home. The MIDAS also assesses disability in family, social, and leisure activities. The MIDAS score is the sum of missed days due to a headache from paid work, housework, and non-work (family, social, leisure) activities; and days at paid work or housework where productivity was reduced by at least half.
Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12
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
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria: 1. ≥2 of the following pain features: * Unilateral * Throbbing * Moderate to severe * Exacerbated with exercise/physical activity 2. ≥1 of the following associated symptoms: * Nausea and/or vomiting * Photophobia and phonophobia
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Xiamen, Fujian, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Shijiazhuang, Hebei, China
Novartis Investigative Site
Zhengzhou, Henan, China
Novartis Investigative Site
Jingzhou, Hubei, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Changsha, Hunan, China
...and 53 more locations
Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12
Change From Baseline in Monthly Acute Headache Medication Days During the Last 4 Weeks of the 12-week Treatment Period
An acute headache medication day was defined as a day when medication was taken to treat acute headache.
Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12
Number of Subjects With Adverse Events as a Measure of Safety
Number of subjects with adverse events was assessed separately in the double-blind treatment period (DBTP) and the open-label treatment period (OLTP).
Time frame: 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.
Number of Subjects With Anti-AMG 334 Antibodies
anti-AMG 334 antibodies assessed for binding and neutralizing)
Time frame: baseline, 20 weeks