A Prospective Structural, Diffusion and Connectomics MRI Study on Migraine Patients Treated With Fremanezumab: The FreMRI Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Definite diagnosis of Migraine With Aura or Migraine Without Aura according to the International Classification of Headache Disorders, 3rd version (IHCD-3) (1).
• Age between 18 and 65 years old.
• Providing signed informed consent form.
• Diagnosis of migraine before 50 years old.
• History of migraine during at least 12 months prior to the study.
• With eight or more migraine days per month within the last three months
Locations
Other Locations
Spain
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Contact Information
Primary
David Garcia Azorin, MD, PhD
davilink@hotmail.com
+34 665872228
Backup
Yesica Gonzalez Osorio, MBA
ygoinvestigacion@outlook.com
+34 634330426
Time Frame
Start Date:2023-03-01
Estimated Completion Date:2025-01-01
Participants
Target number of participants:87
Treatments
Experimental: Fremanezumab
Patients will be treated with 225 mg of subcutaneous injections of Fremanezumab per month.~Patients will do four monthly additional hospital visits. During each visit, occurrence of any adverse event will be interrogated; clinical situation will be analyzed and Fremanezumab will be administered. Visits will be performed at weeks 0, 4 and 8. Last visit will be performed after 12 weeks, without Fremanezumab injection.