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Fremanezumab, Migraine and Sleep

NCT04693533 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-02-27

Study results available
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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.

Conditions

  • Migraine Disorders
  • Sleep Disorder

Interventions

DRUG

Fremanezumab Prefilled Syringe [Ajovy]

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.

Sponsors & Collaborators

Principal Investigators

  • Sait Ashina, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-29
Primary Completion
2024-04-01
Completion
2024-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04693533 on ClinicalTrials.gov