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

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

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 Overview

• Status: Recruiting
• Conditions: Migraine; Headache
• Intervention / Treatment: Drug: Erenumab

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 Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Messoud Ashina, MD; Phone Number: +45 38 63 33 85; Email: ashina@dadlnet.dk
• Study Contact Backup: Name: Hakan Ashina, MD; Phone Number: +45 38 63 20 61; Email: ashinajudo@yahoo.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2600
    • Recruiting
    • Danish Headache Center
    • Contact: Messoud Ashina, MD; Phone Number: +45 38 63 33 85; Email: ashina@dadlnet.dk
    • Contact: Faisal Amin, MD; Phone Number: +45 38 63 31 86; Email: amin.faisal@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-Arm; Erenumab packed in a SureClick® Autoinjector Pen (AI).	Drug: Erenumab; Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI); Other Names: Aimovig

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline	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	Baseline Phase (Day -42 to -28)
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline at Month 6	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	Week 24 ± 2 Weeks
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline at Month 12	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	Week 48 ± 4 Weeks
Headache Diary	Headache diary with daily entries to record migraine-related data.	Baseline Phase (Day -42 to -28) to Month 12
Blood Specimen for Analysis of Biomarkers at Baseline	31 mL Blood for Plasma; 16 mL Blood for Serum; 28 mL Blood for Heparinized Plasma	Baseline Phase (Day -42 to -28)
Blood Specimen for Analysis of Biomarkers at Month 6	31 mL Blood for Plasma; 16 mL Blood for Serum; 28 mL Blood for Heparinized Plasma	Week 24 ± 2 Weeks
Blood Specimen for Analysis of Biomarkers at Month 12	31 mL Blood for Plasma; 16 mL Blood for Serum; 28 mL Blood for Heparinized Plasma	Week 48 ± 4 Weeks
Semi-Structured Interview	In-person semi-structured interview to record migraine-related data.	Baseline Phase (Day -42 to -28)

Collaborators and Investigators

• Sponsor: Danish Headache Center

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Anticipated): July 22, 2025
• Study Completion (Anticipated): July 22, 2025

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: December 13, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: December 18, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Calcitonin Gene-Related Peptide Receptor Antagonists; Erenumab
• Other Study ID Numbers: H-20033264

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes