A Phase 2 Study to Evaluate AMG 334 in Chronic Migraine Prevention
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention
IRAS ID
157581
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2013-001707-36
Clinicaltrials.gov Identifier
Research summary
Chronic migraine is characterised by 15 or more headache days per month (where at least 8 of those days are migraine days). Headache day, is any day in which an individual experiences a qualified migraine or non-migraine headache.
This is a Phase 2, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the effect of AMG 334 compared to placebo on the number of days patients with chronic migraine suffer a migraine within a month (defined as a 28-consecutive day interval for the purpose of this study), as assessed from baseline. Patients that suffer from Medication Overuse headaches (caused by frequent use of headache medication) will be allowed to participate in the trial.
Approximately 490 eligible participants will be randomised at a ratio of 3:2:2 to placebo, AMG 334 70 mg and AMG 334 140 mg.
After signing the informed consent, participants will enter the screening phase (up to 3 weeks). All eligible participants from the screening phase will be enrolled into a 4-week baseline phase. At the day 1 visit, eligible participants from the baseline phase will be randomised into the 12-week double-blind treatment phase and will begin to receive double-blind investigational product. Investigational product (ie, placebo or AMG 334) will be dosed monthly and by sub-cutaneous injection. A safety follow-up visit occurs 12 weeks after completion of the study or early termination (ie, 16 weeks after the last dose of investigational product). It is anticipated that participants will complete 8 study visits in total.
Participants will use an electronic diary (eDiary) every day throughout the baseline phase and double-blind treatment phase to report information about their migraine and non-migraine headaches and acute medication use. Participants will have monthly in-clinic study visits after the week 4 visit.
The planned length of participation for an individual participant is up to 31 weeks.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/1139
Date of REC Opinion
22 Aug 2014
REC opinion
Further Information Favourable Opinion