Overview

Fremanezumab, Migraine and Sleep

Status:
Not yet recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
Summary
The main goal of this study is to determine whether there is a relationship between fremanezumab's ability to prevent migraine and improved sleep quality in migraine patients (fremanezumab is a FDA-approved humanized CGRP monoclonal antibody for the treatment of migraine). This is a within-person study design that examines treatment effects (changes) using high-resolution assessments. To complete the study, each participant will be observed using daily assessments of migraine and sleep outcomes before treatment (baseline: 0 to 30 days), and at 1, 2, and 3 months after treatment (injection 1: days 31-60, injection 2: days 61-90, injection 3: days 91-120). In essence, this creates an interrupted time-series design where repeated interventions are introduced at fixed intervals.
Phase:
Phase 4
Details
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborator:
Teva Pharmaceuticals USA