Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1000 participants
INTERVENTIONAL
2020-09-25
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Single-Arm
Erenumab packed in a SureClick® Autoinjector Pen (AI)
Erenumab
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
Interventions
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Erenumab
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 diiary usage during baseline period
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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Messoud Ashina
Professor of Neurology
Principal Investigators
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Messoud Ashina, MD
Role: PRINCIPAL_INVESTIGATOR
Danish Headache Center
Locations
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Danish Headache Center
Glostrup Municipality, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Thuraiaiyah J, Christensen RH, Al-Khazali HM, Wiggers A, Ashina M, Ashina H. Overlap between perceived triggers, premonitory symptoms and symptom persistence across migraine phases: A REFORM study. Cephalalgia. 2025 Aug;45(8):3331024251364234. doi: 10.1177/03331024251364234. Epub 2025 Aug 26.
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.
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.
Other Identifiers
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20019411
Identifier Type: -
Identifier Source: org_study_id