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

Danish Headache Center1 site in 1 country250 target enrollmentOctober 22, 2020

ConditionsMigraine Headache

InterventionsErenumab

DrugsErenumab

Overview

Phase: Phase 4
Intervention: Erenumab
Conditions: Migraine
Sponsor: Danish Headache Center
Enrollment: 250
Locations: 1
Primary Endpoint: Headache Diary
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 22, 2020

End Date

July 22, 2025

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Danish Headache Center

Responsible Party

Principal Investigator

Messoud Ashina

Prinicipal Investigator

Danish Headache Center

Eligibility Criteria

Inclusion 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.

Arms & Interventions

Single-Arm

Erenumab packed in a SureClick® Autoinjector Pen (AI).

Intervention: Erenumab

Outcomes

Primary Outcomes

Headache Diary

Time Frame: Baseline Phase (Day -42 to -28) to Month 6]

Headache diary with daily entries to record migraine-related data.

Secondary Outcomes

3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline at Month 6(Week 24 ± 2 Weeks)
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline at Month 12(Week 48 ± 4 Weeks)
Blood Specimen for Analysis of Biomarkers at Month 12(Week 48 ± 4 Weeks)
Semi-Structured Interview(Baseline Phase (Day -42 to -28))
Blood Specimen for Analysis of Biomarkers at Month 6(Week 24 ± 2 Weeks)
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline(Baseline Phase (Day -42 to -28))
Headache Diary(Baseline Phase (Day -42 to -28) to Month 12)
Blood Specimen for Analysis of Biomarkers at Baseline(Baseline Phase (Day -42 to -28))