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

Phase 4

Recruiting

• Conditions: Headache; Migraine
• Interventions: Drug: Erenumab

• Registration Number: NCT04674020
• Lead Sponsor: Danish Headache Center

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.

Study Timeline

• Study Start: 2020-10-22
• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-13
• Study First Posted: 2020-12-17
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-18
• Last Update Posted: 2022-01-10
• Primary Completion: 2025-07-22
• Study Completion: 2025-07-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Other Exclusions

• Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
• Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product.
• Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product.
• Evidence of current pregnancy or breastfeeding per subject self-report or medical records
• Subject has known sensitivity to any of the products or components to be administered during dosing
• Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge

Contraindications to MRI:

• Does not wish to be informed about unexpected MRI findings
• Severe claustrophobia
• Implanted magnetic material including pacemaker, prothesis, metal-clips, etc.
• Insulin pump which cannot be removed
• Magnetic foreign object in the body
• Surgical intervention within 6 weeks prior to MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Arm	Erenumab	Erenumab packed in a SureClick® Autoinjector Pen (AI).

Primary Outcome Measures

Name	Time	Method
Headache Diary	Baseline Phase (Day -42 to -28) to Month 6]	Headache diary with daily entries to record migraine-related data.

Secondary Outcome Measures

Name	Time	Method
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline at Month 6	Week 24 ± 2 Weeks	* MP2RAGE; * GRAPPATINI; * Gradient-Recalled-Echo (GRE) Sequence w/wo Magnetization Transfer (MT); * MPRAGE; * Diffusion Tensor Imaging (DTI); * Resting State Functional MRI; * Task-Based Functional MRI (visual stimulation with checkerboard); * 3D FLAIR
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline at Month 12	Week 48 ± 4 Weeks	* MP2RAGE; * GRAPPATINI; * Gradient-Recalled-Echo (GRE) Sequence w/wo Magnetization Transfer (MT); * MPRAGE; * Diffusion Tensor Imaging (DTI); * Resting State Functional MRI; * Task-Based Functional MRI (visual stimulation with checkerboard); * 3D FLAIR
Blood Specimen for Analysis of Biomarkers at Month 12	Week 48 ± 4 Weeks	* 31 mL Blood for Plasma; * 16 mL Blood for Serum; * 28 mL Blood for Heparinized Plasma
Semi-Structured Interview	Baseline Phase (Day -42 to -28)	In-person semi-structured interview to record migraine-related data.
Blood Specimen for Analysis of Biomarkers at Month 6	Week 24 ± 2 Weeks	* 31 mL Blood for Plasma; * 16 mL Blood for Serum; * 28 mL Blood for Heparinized Plasma
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline	Baseline Phase (Day -42 to -28)	* MP2RAGE; * GRAPPATINI; * Gradient-Recalled-Echo (GRE) Sequence w/wo Magnetization Transfer (MT); * MPRAGE; * Diffusion Tensor Imaging (DTI); * Resting State Functional MRI; * Task-Based Functional MRI (visual stimulation with checkerboard); * 3D FLAIR
Headache Diary	Baseline Phase (Day -42 to -28) to Month 12	Headache diary with daily entries to record migraine-related data.
Blood Specimen for Analysis of Biomarkers at Baseline	Baseline Phase (Day -42 to -28)	* 31 mL Blood for Plasma; * 16 mL Blood for Serum; * 28 mL Blood for Heparinized Plasma

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Copenhagen, Denmark