Clinical trial NCT03812224
Conditions: Migraine
Sponsor: Amgen
Start date: 2019-04-12; Completion date: 2020-11-25
Enrollment: 261 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).

Detailed description:
Migraine prevention is an area of a large unmet medical need, with existing therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) receptor antagonism is a novel approach to migraine preventive therapy. Erenumab is a human monoclonal antibody against canonical CGRP receptor. The present study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).

The study consists of a screening period (up to 7 weeks, including a 4-week baseline period), a 24-week double-blind treatment period (DBTP), a 28-week open-label treatment period (OLTP), and an 8-week safety follow-up period (12 weeks after the last dose of investigational product).

Arms: arm 1: Participants were to receive erenumab 70 mg once a month for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period. arm 2: Participants were to receive placebo to erenumab once a month for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
Interventions: intervention 1: Erenumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection once a month intervention 2: Administered by subcutaneous injection once a month

Protocol documents:
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Product:  AMG 334 (erenumab) 
Protocol Number:  20170609 
Date:  19 December 2018 
Page 1 of 29 
CONFIDENTIAL 
 
 
Amendment 1 
Protocol Title:  A Phase 3 Japanese Randomized, Double-blind, 
Placebo-controlled Study to Evaluate the Efficacy and Safety of Erenumab in 
Migraine Prevention 
 
Amgen Protocol Number AMG 334 (erenumab) 20170609 
 
Amendment Date: 
19 December 2018 
 
Rationale: 
The purpose of this protocol amendment is to add in an additional Patient-reported 
Outcome (PRO) to evaluate the 
 
 
 over months 4, 5, and 6 of the double-blind treatment period (DBTP) during this 
study. 
In addition, the following were clarified to ensure alignment with study procedures: 
• 
Update contraception changes to align with contraception requirements approved 
by the PMDA in Japan. 
• 
Update double-blind treatment phase to double-blind treatment period (DBTP). 
• 
Add clinical outcomes assessments to be performed/collected at Day 1, and 
include a
and eDiary COA 
collection in the DBTP and daily during weeks 33 to 36 and weeks 49 to 52 in the 
OLTP. 
• 
Add investigational product background description that study drug, erenumab, is 
a genetically recombinant drug manufactured using Chinese hamster ovary 
(CHO) cell line. 
• 
Add the exploratory objective and endpoints to evaluate the 
 
 
 
 
 
• 
Clarify definitions of terms included in endpoints for headache day and remove 
language for migraine attack. 
• 
Update language for inclusion criteria for migraine frequency and exclusion 
criteria for prior/concomitant therapy for preventive treatment of migraine. 
• 
Add language for exclusion criteria for subject risk of self-harm or harm to others. 
Approved 
 
 


Product:  AMG 334 (erenumab) 
Protocol Number:  20170609 
Date:  19 December 2018 
Page 2 of 29 
CONFIDENTIAL 
 
 
• 
Update language for subject enrollment to clarify that subjects may proceed to 
the baseline period if Part 1 eligibility criteria is not met, or subjects will be 
screen-failed if all Part 2 eligibility criteria is not met. 
• 
Remove language that individuals who do not meet the criteria for participation in 
the study (screen failure) may be rescreened 1 time. 
• 
Add that in addition to weeks 24, 32, 36, 40, 44, and 48, erenumab will also be 
administered at week 28 during the 28-week open-label treatment period. 
• 
Add that anti-CGRP monoclonal antibody use, including current or prior use, is 
excluded throughout the study. 
• 
Remove protocol-specific criteria language from reasons for removal from study. 
• 
Add language to describe the 
 
• 
Update the volume of blood samples to be collected for measurement of blood 
concentrations of erenumab as specified in the Schedule of Activities. 
• 
Administrative, typographical, and formatting changes were made throughout the 
protocol. 
Approved 
 
 

SAP_001.pdf: 
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