Open-label Extension Study to Assess the Safety and Efficacy of AMG334
Research type
Research Study
Full title
An Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 334
IRAS ID
166050
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2013-005311-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 14 days
Research summary
This is a multicentre, open-label study designed to assess the long-term safety and efficacy of AMG 334. AMG 334 is an investigational product that works by blocking a cell receptor called the CGRP receptor, which is believed to be a key factor in causing migraines; by doing so, AMG 334 may help to prevent chronic migraines. This study primarily aims to characterise the safety and tolerability of long-term administration of AMG 334 in participants with chronic migraine.
Study participants will be patients with a history of chronic migraine, as assessed by the research team. Only participants who complete the 12-week double-blind treatment phase of the AMG 334 parent study in chronic migraine and meet all eligibility criteria for this open-label study will be able to enrol, if they wish. Enrolment into this study should occur within 14 days after the parent study’s week 12 visit is completed.
All participants will receive a dose of 70 mg open-label AMG 334 by subcutaneous (under the skin) injections during their monthly visits to the hospital for a period of 13 months. This is followed by a 12-week safety follow up visit, which occurs 16 weeks after the last dose of investigational product. Throughout the course of the study, electrocardiograms (ECGs) and blood and urine tests will be performed and vital signs will be measured to assess the safety and well-being of participants. Completion of patient and clinician administered questionnaires will be required throughout the study to collect information for the participants’ headache and migraine status.
The study is funded by the sponsor company, Amgen Inc. and will be run at specialist headache treatment centres.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0521
Date of REC Opinion
19 May 2015
REC opinion
Further Information Favourable Opinion