Fremanezumab, Migraine and Sleep

Summary

Participation Requirements

Description

The study involves 3 visits to the headache clinic and 2 virtual appointments: In clinic visit 1 (day 0), subjects will learn about the study and if they agree to participate, will be consented and screened for eligibility. Those deemed to be eligible will be asked to fill a headache questionnaire a...

The study involves 3 visits to the headache clinic and 2 virtual appointments: In clinic visit 1 (day 0), subjects will learn about the study and if they agree to participate, will be consented and screened for eligibility. Those deemed to be eligible will be asked to fill a headache questionnaire and then taught how to fill at home a daily e-diary for sleep and a daily e-diary for headache. In clinic visit 2 (day 30), subjects will return to the headache clinic to review their e-diaries and receive the first treatment. The treatment is 225 mg (dissolved in 1.5 ml saline) fremanezumab. Fremanezumab (Ajovy) is a month-long-acting anti-CGRP injection that patients are taught to self-administer at home. In virtual appointment 1 (day 60), we will review participants' headache and sleep diaries 1 month after receiving the 1st injection and if needed, guide them through the self-administration of the 2nd injection. This appointment will be conducted by either one of the study physicians or the study nurse via StarLeaf. The doses for the two virtual appointments will be shipped to subjects' residences ahead of their monthly dosage days. The study team will obtain the study medication from the Research pharmacy via the usual SOP and mail it to the subjects via a traceable method at ambient storage. Supply will be mailed within close proximity to the "visit" day. Subjects will have the option to come in to the headache clinic for the visit if they so wish. In virtual appointment 2 (day 90), we will review participants' headache and sleep diaries 1 month after receiving the 2nd injection and if needed, guide them through the self-administration of the 3rd injection. This appointment will be conducted by either one of the study physicians or the study nurse via StarLeaf. In clinic visit 3 (day 120), participants will return to the headache clinic to summarize their experience, review their 120-days e-diaries, and provide any feedback they may have about their experience with fremanezumab. Assessments of headache and sleep: At screening (visit 1), headache severity and impact will be assessed based on patients' interviews and HIT-6. Sleep quality will be assessed using the Insomnia Severity Index. (https://cbtscience.files.wordpress.com/2014/02/insomniaseverityindex.pdf). On days 30, 60, 90 and 120, baseline and treatment impact on headache and sleep will be assessed using the Headache e-diary and the consensus sleep diary [Carney et al., (2012) The consensus sleep diary: Standardizing prospective sleep self-monitoring, Sleep Vol.35, No.2, pp.287-302], the latter of which captures total sleep time, sleep latency, wake after sleep onset, number of awakenings, quality, sleep efficiency, and trouble staying awake.

Tracking Information