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

NCT04674020 | Unknown Phase 4

• 1 other identifier: H-20033264
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Headache

Outcome Measures

Primary Outcomes (1)

• Headache Diary

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

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

Secondary Outcomes (8)

• 3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline

  Baseline Phase (Day -42 to -28)

• 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

• 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)

Study Arms (1)

Single-Arm

EXPERIMENTAL

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

Drug: Erenumab

Interventions

Erenumab DRUG

Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)

Also known as: Aimovig

Single-Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Copenhagen, 2600, Denmark

RECRUITING

Related Publications (3)

• Karlsson WK, Christensen RH, Al-Khazali HM, Kallemose T, Jawad BN, Andersen O, Ashina M, Ashina H. Plasma SuPAR and therapeutic response to erenumab in migraine: a REFORM study. J Headache Pain. 2025 Apr 24;26(1):86. doi: 10.1186/s10194-025-02037-9.

  PMID: 40275185 DERIVED

• Christensen RH, Ashina H, Al-Khazali HM, Zhang Y, Tolnai D, Poulsen AH, Cagol A, Hadjikhani N, Granziera C, Amin FM, Ashina M. Differences in Cortical Morphology in People With and Without Migraine: A Registry for Migraine (REFORM) MRI Study. Neurology. 2024 May;102(9):e209305. doi: 10.1212/WNL.0000000000209305. Epub 2024 Apr 17.

  PMID: 38630960 DERIVED

• Karlsson WK, Ashina H, Cullum CK, Christensen RH, Al-Khazali HM, Amin FM, Ashina M; REFORM Investigators. The Registry for Migraine (REFORM) study: methodology, demographics, and baseline clinical characteristics. J Headache Pain. 2023 Jun 12;24(1):70. doi: 10.1186/s10194-023-01604-2.

  PMID: 37303034 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Messoud Ashina, MD

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 17, 2020
• Study Start: October 22, 2020
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: January 10, 2022

Record last verified: 2021-12

Locations

DK (1)