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The FreMRI Study: Advanced MRI on Migraine Patients Treated With Fremanezumab

NCT06244823 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2024-02-06

No results posted yet for this study

Summary

The goal of this open-label, single-blind, controlled-trial is to evaluate brain changes evaluated with diffusion Magnetic Resonance Imaging (MRI) and functional MRI in patients with high-frequency episodic migraine and chronic migraine that will be treated with Fremanezumab, 12 weeks after the treatment onset, compared with the baseline.

Type of study: Phase IV clinical trial Participant population: high-frequency episodic migraine and chronic migraine. Participants will be treated with Fremanezumab.

Conditions

  • Migraine Disorders
  • Migraine With Aura
  • Migraine Without Aura
  • Brain Diseases

Interventions

DRUG

Fremanezumab Prefilled Syringe

MRI will be scanned prior to the first administration of Fremanezumab, within 0-14 days, prior to Fremanezumab injection. The second MRI will be acquired at 12 ± 1 weeks after the first Fremanezumab injection.Images will be acquired during interictal periods, defined as at least 24 hours from last migraine attack. All the scans will be acquired during the same session, starting with the T1-weighted scan, followed by the diffusion-weighted scan and ending with the rs-fMRI scan. Total acquisition time for a single subject is approximately 28 minutes, divided in the following periods of time: six minutes for the T1-weighted scan, 12 minutes for the diffusion-weighted scan and 10 minutes for the rs-fMRI scan. If we consider patient preparation, obtainment of documents and informed consent form, the whole process will take about 50-70 minutes.

Sponsors & Collaborators

  • University of Valladolid

    collaborator OTHER

  • Complejo Asistencial Universitario de Palencia

    collaborator UNKNOWN

  • Complejo Público Asistencial de Zamora

    collaborator UNKNOWN

  • Hospital Clínico Universitario de Valladolid

    lead OTHER

Principal Investigators

  • Angel L Guerrero Peral, MD, PhD · Sanidad de Castilla y León

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-10-01
Completion
2025-01-01

Countries

  • Spain

Study Locations

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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 NCT06244823 on ClinicalTrials.gov