Status:
UNKNOWN
BIOmarkers of MIGraine: a Proof of Concept Study Based on the Stratification of Responders to CGRP Monoclonal Antibodies
Lead Sponsor:
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborating Sponsors:
Ministry of Health, Italy
Conditions:
Migraine
Eligibility:
All Genders
25-55 years
Brief Summary
Migraine is the 2nd most disabling neurological disease. It affects 14.7% of the population (children and adults) of whom 80% are female. In the European Union, the total annual cost of migraine is of...
Detailed Description
Almost 15% of European citizens suffer from migraine and its comorbidities. Migraine is the second most disabling chronic neurological disease, with devastating repercussions on the life of those who ...
Eligibility Criteria
Inclusion
- Migraine patients
- Adults between 25 and 55 years of age of both gender;
- European background;
- Patients diagnosed with high-frequency migraine (HFM) 8 or more migraine days days/month) or CM with or without aura (\>15 headache days migraine/month, of which 8 have migraine characteristics) according to the International Classification of Headache Disorders, 3rd edition, (ICHD-3);
- Females have to be postmenopausal for at least one year, surgically sterile or otherwise incapable of pregnancy, or using an acceptable method of birth control.
- Healthy controls
- Adults between 25 and 55 years of age of both genders;
- European background;
- Absence of any past or first-degree familial history of recurrent primary or secondary headache disorders.
Exclusion
- For the clinical population:
- Headache on more than 25 days/month in the last 3 months;
- Medication overuse according to the ICHD-3 criteria.
- For the entire study population (migraine and healthy controls)
- Presence of any other significant medical condition (neurological disorders, severe psychiatric illness or cardiovascular disease);
- Evidence of drug, smoking or alcohol abuse or dependence within 12 months prior to V1, based on medical records or patient self-report. An alcohol consumption \>100mg/week will be considered an abuse;
- Pregnant or breastfeeding women;
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant who are not on contraception;
- Concomitant use of other migraine preventive drugs that may interfere with the endpoints of the study.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT04503083
Start Date
January 15 2021
End Date
March 1 2023
Last Update
April 29 2021
Active Locations (3)
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1
Institut für Systemische Neurowissenschaften, Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20357
2
Headache Science Center
Pavia, Italy, 27100
3
Headache Research Group Vall d'Hebron Institute of Research
Barcelona, Catalonia, Spain, 8009