Registry for Migraine - Structural and Functional MRI Before and After Erenumab Treatment (REFORM)
Primary Purpose
Migraine, Headache
Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Erenumab
Sponsored by
About this trial
This is an interventional other trial for Migraine
Eligibility Criteria
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
Sites / Locations
- Danish Headache CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single-Arm
Arm Description
Erenumab packed in a SureClick® Autoinjector Pen (AI).
Outcomes
Primary Outcome Measures
Headache Diary
Headache diary with daily entries to record migraine-related data.
Secondary Outcome Measures
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
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
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
Headache Diary
Headache diary with daily entries to record migraine-related data.
Blood Specimen for Analysis of Biomarkers at Baseline
31 mL Blood for Plasma
16 mL Blood for Serum
28 mL Blood for Heparinized Plasma
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
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
Semi-Structured Interview
In-person semi-structured interview to record migraine-related data.
Full Information
NCT ID
NCT04674020
First Posted
December 13, 2020
Last Updated
December 18, 2021
Sponsor
Danish Headache Center
1. Study Identification
Unique Protocol Identification Number
NCT04674020
Brief Title
Registry for Migraine - Structural and Functional MRI Before and After Erenumab Treatment
Acronym
REFORM
Official Title
Registry for Migraine - Structural and Functional Magnetic Resonance Imaging Before and After Erenumab Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
July 22, 2025 (Anticipated)
Study Completion Date
July 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Headache
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open-label
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single-Arm
Arm Type
Experimental
Arm Description
Erenumab packed in a SureClick® Autoinjector Pen (AI).
Intervention Type
Drug
Intervention Name(s)
Erenumab
Other Intervention Name(s)
Aimovig
Intervention Description
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
Primary Outcome Measure Information:
Title
Headache Diary
Description
Headache diary with daily entries to record migraine-related data.
Time Frame
Baseline Phase (Day -42 to -28) to Month 6]
Secondary Outcome Measure Information:
Title
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline
Description
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
Time Frame
Baseline Phase (Day -42 to -28)
Title
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline at Month 6
Description
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
Time Frame
Week 24 ± 2 Weeks
Title
3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) at Baseline at Month 12
Description
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
Time Frame
Week 48 ± 4 Weeks
Title
Headache Diary
Description
Headache diary with daily entries to record migraine-related data.
Time Frame
Baseline Phase (Day -42 to -28) to Month 12
Title
Blood Specimen for Analysis of Biomarkers at Baseline
Description
31 mL Blood for Plasma
16 mL Blood for Serum
28 mL Blood for Heparinized Plasma
Time Frame
Baseline Phase (Day -42 to -28)
Title
Blood Specimen for Analysis of Biomarkers at Month 6
Description
31 mL Blood for Plasma
16 mL Blood for Serum
28 mL Blood for Heparinized Plasma
Time Frame
Week 24 ± 2 Weeks
Title
Blood Specimen for Analysis of Biomarkers at Month 12
Description
31 mL Blood for Plasma
16 mL Blood for Serum
28 mL Blood for Heparinized Plasma
Time Frame
Week 48 ± 4 Weeks
Title
Semi-Structured Interview
Description
In-person semi-structured interview to record migraine-related data.
Time Frame
Baseline Phase (Day -42 to -28)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Messoud Ashina, MD
Phone
+45 38 63 33 85
Email
ashina@dadlnet.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Hakan Ashina, MD
Phone
+45 38 63 20 61
Email
ashinajudo@yahoo.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, MD
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center
City
Copenhagen
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, MD
Phone
+45 38 63 33 85
Email
ashina@dadlnet.dk
First Name & Middle Initial & Last Name & Degree
Faisal Amin, MD
Phone
+45 38 63 31 86
Email
amin.faisal@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Registry for Migraine - Structural and Functional MRI Before and After Erenumab Treatment
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