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Registry for Migraine - Structural and Functional MRI Before and After Erenumab Treatment | Clinical Trials | Clareo Health

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Registry for Migraine - Structural and Functional MRI Before and After Erenumab Treatment

Registry for Migraine - Structural and Functional Magnetic Resonance Imaging Before and After Erenumab Treatment

NCT04674020•Danish Headache Center

View on ClinicalTrials.gov

Summary

This study aims to investigate structural and functional cerebral changes using magnetic resonance imaging before and after treatment with erenumab in patients with migraine.

Detailed Description

Migraine is a prevalent neurological disorder and a leading cause of years lived with disability worldwide. As of recent, therapies targeting calcitonin gene-related peptide (e.g. erenumab) have been approved for the preventive treatment of migraine. This study aims to investigate structural and functional cerebral changes using magnetic resonance imaging before and after treatment with erenumab in patients with migraine.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Criteria:
•Subject has provided informed consent prior to initiation of any study-specific activities/procedures
•Age greater than or equal to 18 years upon entry into screening
•History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self report
•Greater than or equal to 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening after baseline period
•Must have demonstrated greater than or equal to 75% compliance in headache diary usage during baseline period

Exclusion Criteria

•Subjects are excluded from the study if any of the following criteria apply:
•Disease Related
•Greater than 50 years of age at migraine onset
•History of cluster headache or hemiplegic migraine headache
•Inability to differentiate between migraine from other headaches
•The subject is at risk of self-harm or harm to others as evidenced by past suicidal behaviour
•History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion Prior/Concomitant Therapy
•Previously received erenumab (Aimovig®)
•Received an anti-CGRP monoclonal antibody within 3 months prior to the start of the baseline period Prior/Concurrent Clinical Study Experience
•Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study (ies). Other investigational procedures while participating in this study are excluded.
+14 more criteria

Locations (1)

Danish Headache Center

Copenhagen, Denmark

Key Dates

Start Date

October 22, 2020

Primary Completion Date

July 22, 2025

Completion Date

July 22, 2025

Last Updated

January 10, 2022

Enrollment

250

ESTIMATED participants

Conditions

MigraineHeadache

Interventions

Erenumab

DRUG

Contacts

Messoud Ashina, MD

CONTACT

+45 38 63 33 85 ashina@dadlnet.dk

Hakan Ashina, MD

CONTACT

+45 38 63 20 61 ashinajudo@yahoo.dk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Registry for Migraine - Structural and Functional MRI Before and After Erenumab Treatment

Inclusion Criteria

Exclusion Criteria

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