Advanced MRI for migraine patients treated with Fremanezumab

A Prospective Structural, Diffusion and Connectomics MRI Study on Migraine Patients Treated With Fremanezumab: The FreMRI Study

This study is testing how the migraine medication Fremanezumab affects brain changes in people with frequent migraines by using advanced MRI scans before and after treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 87 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Hospital Clínico Universitario de Valladolid (Academic / other)
• Drugs / interventions: Fremanezumab
• Locations: 1 site (Valladolid)
• Trial ID: NCT06244823 on ClinicalTrials.gov

What this trial studies

This open-label, single-blind, controlled trial aims to evaluate brain changes in patients with high-frequency episodic and chronic migraines treated with Fremanezumab. Participants will undergo diffusion and functional MRI scans before treatment and 12 weeks after starting the medication. The study will assess structural and functional changes in the brain associated with migraine disorders. A total of 87 patients will be enrolled, with a study duration of 8 months per participant.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of migraine with or without aura and experiencing eight or more migraine days per month.

Not a fit: Patients with other primary headache disorders or those who have previously used Fremanezumab or similar monoclonal antibodies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the brain changes associated with migraine treatment, potentially leading to improved management strategies.

How similar studies have performed: Other studies have shown promising results with CGRP-targeting therapies in migraine treatment, suggesting a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Definite diagnosis of Migraine With Aura or Migraine Without Aura according to the International Classification of Headache Disorders, 3rd version (IHCD-3) (1).
2. Age between 18 and 65 years old.
3. Providing signed informed consent form.
4. Diagnosis of migraine before 50 years old.
5. History of migraine during at least 12 months prior to the study.
6. With eight or more migraine days per month within the last three months

Exclusion Criteria:

1.Presence of other primary headache disorders other than infrequent tension-type headache or medication overuse headache (MOH).

1. Participation of MOH patients will be restricted to a maximum of 50% of the total sample.
2. Prior use of Fremanezumab or another monoclonal antibody targeting CGRP or CGRP receptor.
3. Prior use of less than two or more than four preventive drugs according to the local national guidelines (34), with inadequate response after sufficient doses and enough time or lack of tolerability.
4. Any medical condition that might prevent study completion or interfere with interpretation of results.
5. History of any neurological or neurosurgical condition affecting the brain.
6. History of moderate-severe head trauma.
7. History of other chronic pain syndrome with a frequency of five or more days of pain per month.
8. Presence of daily headache
9. Pregnant or breastfeeding women.
10. Current or recent use of any other prophylactic treatment in the preceding five half-lives prior to the start.
11. Exposure to onabotulinumtoxinA in the preceding four months.
12. Any expected surgery during the study.
13. Use of opioids or barbiturates.
14. Any condition contraindicating an MRI acquisition.
15. Completing headache diary at least 80% of the time during the screening period

Where this trial is running

Valladolid

• Hospital Clínico Universitario de Valladolid — Valladolid, Spain (Recruiting)

Study contacts

• Principal investigator: Angel L Guerrero Peral, MD, PhD — Sanidad de Castilla y León
• Study coordinator: David Garcia Azorin, MD, PhD

Conditions Migraine Disorders; Migraine With Aura; Migraine Without Aura; Brain Diseases; Treatment outcomes; Preventive treatment; Brain functional changes; Brain structural changes