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

Launched by HOSPITAL CLÍNICO UNIVERSITARIO DE VALLADOLID · Jan 29, 2024

Keywords

ClinConnect Summary

The FreMRI Study is a clinical trial designed to learn more about how treatment with a medication called Fremanezumab affects the brains of people who experience frequent migraines. Specifically, the study will use advanced MRI techniques to look for changes in the brain after 12 weeks of treatment. This trial is open to adults aged 18 to 65 who have been diagnosed with migraines, either with or without aura (which are visual disturbances that can occur before a migraine). To participate, individuals must have experienced at least eight migraine days in a month over the past three months and have a history of migraines for at least a year.

Participants in this study can expect to receive Fremanezumab and undergo MRI scans to help researchers understand how the treatment may impact their brain. It’s important to note that certain conditions could exclude someone from participating, such as having other types of headaches, a history of significant brain injuries, or being pregnant or breastfeeding. Overall, this study aims to provide valuable information that could improve migraine treatment in the future.

Gender

ALL

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