drugset / Trial / NCT04693533

Fremanezumab, Migraine and Sleep

NCT04693533

NaSingle-groupOpen-labelOther

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.

Timeline

Start
2021-07-29
Primary completion
2024-04-01
Completion
2024-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fremanezumab Monoclonal antibody 225 mg