Clinical trial
A Prospective Structural, Diffusion and Connectomics MRI Study on Migraine Patients Treated With Fremanezumab: The FreMRI Study
Name
CASVE 20-469
Description
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.
Trial arms
Trial start
2023-03-01
Estimated PCD
2024-10-01
Trial end
2025-01-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Fremanezumab
Size
87
Primary endpoint
Morphometric MRI parameters change from baseline during the 12-week period after the administration of Fremanezumab 1
Baseline, week 12-15
Morphometric MRI parameters change from baseline during the 12-week period after the administration of Fremanezumab 2.
Baseline, week 12-15
Morphometric MRI parameters change from baseline during the 12-week period after the administration of Fremanezumab 3.
Baseline, week 12-15
Morphometric MRI parameters change from baseline during the 12-week period after the administration of Fremanezumab 4.
Baseline, week 12-15
Diffusion MRI descriptors change from baseline during the 12-week period after the administration of Fremanezumab 1.
Baseline, week 12-15
Diffusion MRI descriptors change from baseline during the 12-week period after the administration of Fremanezumab 2.
Baseline, week 12-15
Diffusion MRI descriptors change from baseline during the 12-week period after the administration of Fremanezumab 3.
Baseline, week 12-15
Diffusion MRI descriptors change from baseline during the 12-week period after the administration of Fremanezumab 4.
Baseline, week 12-15
Structural connectivity change from baseline during the 12-week period after the administration of Fremanezumab 1.
Baseline, week 12-15
Structural connectivity change from baseline during the 12-week period after the administration of Fremanezumab 2.
Baseline, week 12-15
Structural connectivity change from baseline during the 12-week period after the administration of Fremanezumab 3.
Baseline, week 12-15
Resting-state functional connectivity change from baseline during the 12-week period after the administration of Fremanezumab.
Baseline, week 12-15
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The present study is an open-label, controlled-trial, single-blind trial analyzing brain changes measured by dMRI and fMRI in patients with high frequency episodic migraine and chronic migraine will be treated with Fremanezumab, 12 weeks after treatment.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Given that the efficacy of Fremanezumab has been established in the pivotal trials and due to sample-size reasons, we chose an open-label study. However, in order to avoid biases as much as possible, we will blind clinical data to the imaging analysts. Patients, clinicians involved in the Fremanezumab administration and data analysts cannot be blind to the information.'}}, 'enrollmentInfo': {'count': 87, 'type': 'ESTIMATED'}}
Updated at
2024-02-06
1 organization
1 product
4 indications
Organization
Hospital Clínico Universitario de ValladolidProduct
FremanezumabIndication
Migraine DisordersIndication
Migraine With AuraIndication
Migraine Without AuraIndication
Brain Diseases