A Phase 3 Study to Evaluate AMG334 in Episodic Migraine Prevention
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention.
IRAS ID
180616
Contact name
Matthew Laybourne
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2014-004464-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 9 days
Research summary
This is a multicentre, double-blind placebo controlled phase 3 study in patients with episodic migraine. These patients typically experience migraines for less than 15 days in a month. The aim of this study is to evaluate the effect of AMG334 compared to placebo on the change in the number of days patients suffer from migraine each month.
AMG334 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, AMG334 may help to prevent episodic migraines. This study will primarily assess whether AMG334 prevents migraines and whether it causes any side effects.
After consenting, participants will enter the screening phase (up to 3 weeks), following which eligible participants will be enrolled into a 4-week baseline phase. At the end of baseline, participants meeting an additional set of criteria will be randomised into the 24-week double-blind treatment phase, to begin receiving investigational product. Approximately 852 participants will be randomised to receive either placebo, AMG334 70 mg or AMG334 140 mg. On completion of the double-blind treatment phase, all patients will begin receiving AMG334 for 24 weeks but the dose will not be known. A safety follow-up visit occurs 12 weeks after study completion or early termination.
It is anticipated that participants will complete 17 on site study visits and 1 telephone call. The planned length of participation for each participant is up to 71 weeks.
Participants will use an electronic diary each day from the start of baseline through to the end of the active treatment phase, to collect information about migraines, non-migraine headaches and acute medication taken for these.
The study is funded by the sponsor, Amgen Inc. and will be run at specialist headache treatment centres and clinical research units.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0261
Date of REC Opinion
29 Sep 2015
REC opinion
Further Information Favourable Opinion