REFORM: Registry for Migraine - Structural and Functional MRI Before and After Erenumab Treatment
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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 Design
Arms and Interventions
| 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:
|
Outcome Measures
Primary Outcome Measures
- Headache Diary [Baseline Phase (Day -42 to -28) to Month 6]]
Headache diary with daily entries to record migraine-related data.
Secondary Outcome Measures
- 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
- 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
- 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
- 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
- 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.
Eligibility Criteria
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
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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
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Previously received erenumab (Aimovig®)
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Received an anti-CGRP monoclonal antibody within 3 months prior to the start of the baseline period Prior/Concurrent Clinical Study Experience
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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
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Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
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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.
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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.
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Evidence of current pregnancy or breastfeeding per subject self-report or medical records
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Subject has known sensitivity to any of the products or components to be administered during dosing
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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:
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Does not wish to be informed about unexpected MRI findings
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Severe claustrophobia
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Implanted magnetic material including pacemaker, prothesis, metal-clips, etc.
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Insulin pump which cannot be removed
-
Magnetic foreign object in the body
-
Surgical intervention within 6 weeks prior to MRI
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Danish Headache Center | Copenhagen | Denmark | 2600 |
Sponsors and Collaborators
- Danish Headache Center
Investigators
- Principal Investigator: Messoud Ashina, MD, Danish Headache Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-20033264