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

Phase 3

Completed

Conditions: Migraine

Interventions: Other: Placebo
Biological: Erenumab

Registration Number: NCT03867201

Lead Sponsor: Novartis Pharmaceuticals

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 557

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Administered by pre-filled syringe
Erenumab	Erenumab	Administered by pre-filled syringe

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period	baseline (4 weeks period prior to start of study drug), week 9 to 12	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

Secondary Outcome Measures

Name	Time	Method
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	baseline (4 weeks period prior to start of study drug), week 9 to 12	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.
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	baseline (4 weeks period prior to start of study drug), week 9 to 12	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
Change From Baseline in Monthly Acute Headache Medication Days During the Last 4 Weeks of the 12-week Treatment Period	baseline (4 weeks period prior to start of study drug), week 9 to 12	An acute headache medication day was defined as a day when medication was taken to treat acute headache.
Number of Subjects With Adverse Events as a Measure of Safety	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 adverse events was assessed separately in the double-blind treatment period (DBTP) and the open-label treatment period (OLTP).
Number of Subjects With Anti-AMG 334 Antibodies	baseline, 20 weeks	anti-AMG 334 antibodies assessed for binding and neutralizing)