Last updated: December 18, 2021
Sponsor: Danish Headache Center
Overall Status: Active - Recruiting
Phase
4
Condition
Migraine (Adult)
Oral Facial Pain
Chronic Pain
Treatment
N/AClinical Study ID
NCT04674020
H-20033264
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Criteria: Inclusion Criteria:
- Subject has provided informed consent prior to initiation of any study-specificactivities/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 monthsbefore screening according to the International Headache Society (IHS) ClassificationICHD-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 monthon average across the 3 months before screening after baseline period
- Must have demonstrated greater than or equal to 75% compliance in headache diary usageduring baseline period
Exclusion
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 suicidalbehaviour
- 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 investigatorwould pose a risk to subject safety or interfere with the study evaluation, proceduresor completion Prior/Concomitant Therapy
- Previously received erenumab (Aimovig®)
- Received an anti-CGRP monoclonal antibody within 3 months prior to the start of thebaseline period Prior/Concurrent Clinical Study Experience
- Currently receiving treatment in another investigational device or drug study, or lessthan 30 days or 5 half-lives since ending treatment on another investigational deviceor drug study (ies). Other investigational procedures while participating in thisstudy are excluded. Other Exclusions
- Female subjects of childbearing potential with a positive pregnancy test assessed atscreening or day 1 by a urine pregnancy test.
- Female subject is pregnant or breastfeeding or planning to become pregnant orbreastfeed during treatment and for an additional 16 weeks after the last dose ofinvestigational product.
- Female subjects of childbearing potential unwilling to use 1 acceptable method ofeffective contraception during treatment and for an additional 16 weeks after the lastdose of investigational product.
- Evidence of current pregnancy or breastfeeding per subject self-report or medicalrecords
- Subject has known sensitivity to any of the products or components to be administeredduring dosing
- Subject likely to not be available to complete all protocol-required study visits orprocedures, and/or to comply with all required study procedures to the best of thesubject 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 Design
Total Participants: 250
Study Start date:
October 22, 2020
Estimated Completion Date:
July 22, 2025
Study Description
Connect with a study center
Danish Headache Center
Copenhagen, 2600
DenmarkActive - Recruiting
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