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A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache


20170703 is a study in adult participants with Chronic Migraine (CM) and Medication Overuse Headache (MOH). The purpose of conducting the study is to better understand the effectiveness and safety of erenumab compared to placebo when given to a targeted population diagnosed with CM and MOH that have at least one preventative treatment failure, to see if it makes any changes in the number of days participants suffer from monthly headache days (MHD) and are able to revert the medication overuse status.

After consenting, participants will enter the screening period (up to 7 weeks), following which eligible participants (approximately 687) will be randomised in a 1:1:1 fashion to either placebo, erenumab 70mg or erenumab 140mg for 24 weeks (double blind treatment phase (DBTP)), the participants then have the option to enter the open-label treatment phase (OLTP) for 28 weeks. Participants on erenumab will continue with the same treatment whereas those participants previously on placebo will be randomised into either erenumab 70mg or erenumab 140mg. At the end of treatment, participants will have an End of Study visit 4 weeks after the last dose.

Participants are expected to complete 12 on site study visits and 4 telephone calls. The planned length of participation for each participant is up to 59 weeks.

Participants will use an electronic diary daily during the DBTP and then part of the OLTP in order to collect information about headaches, medication and complete questionnaires.

Erenumab works by blocking a cell receptor, which is a key factor in causing migraines. Participants that suffer from migraines, frequently take pain medication that overtime can become less effective in treating migraines and lead to a condition known as MOH, by taking erenumab the study is trying to see if it will revert the medication overuse status.