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

December 18, 2021 updated by: Messoud Ashina, Danish Headache Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2600
        • Recruiting
        • Danish Headache Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Headache Diary
Time Frame: Baseline Phase (Day -42 to -28) to Month 6]
Headache diary with daily entries to record migraine-related data.
Baseline Phase (Day -42 to -28) to Month 6]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline
Time Frame: 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
Baseline Phase (Day -42 to -28)
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline at Month 6
Time Frame: 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
Week 24 ± 2 Weeks
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline at Month 12
Time Frame: 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
Week 48 ± 4 Weeks
Headache Diary
Time Frame: Baseline Phase (Day -42 to -28) to Month 12
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
Time Frame: Baseline Phase (Day -42 to -28)
  • 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
Time Frame: Week 24 ± 2 Weeks
  • 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
Time Frame: Week 48 ± 4 Weeks
  • 31 mL Blood for Plasma
  • 16 mL Blood for Serum
  • 28 mL Blood for Heparinized Plasma
Week 48 ± 4 Weeks
Semi-Structured Interview
Time Frame: Baseline Phase (Day -42 to -28)
In-person semi-structured interview to record migraine-related data.
Baseline Phase (Day -42 to -28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings