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

Last Updated: 2025-10-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

557 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2024-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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