NCT04503083Befejeződött
BIOmarkers of MIGraine: a Proof of Concept Study Based on the Stratification of Responders to CGRP Monoclonal Antibodies
A Multidisciplinary Approach to the Identification of BIOmarkers of MIGraine: a Proof of Concept Study Based on the Stratification of Responders to CGRP Monoclonal Antibodies
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 16.
Rövid összefoglaló (regiszter, angolul)
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 111 billion euros. If not adequately treated, migraine can evolve into the more severe chronic form (CM), defined by >15 headache days/month, where burden and costs increase exponentially. Until very recently, available preventive treatments for migraine were non-specific, of limited efficacy and scarce tolerability. In 2018, monoclonal antibodies (mABs) against calcitonin gene-related peptide (CGRP) receptor have been approved. Since CGRP is one of the main modulators of the trigeminal system, mABs against CGRP are the first specific preventive treatment for migraine ever developed. They are highly effective in a subgroup of patients, well tolerated, but costly. In this frame, the main objective of BIOMIGA project is to identify predictive biomarkers of response to CGRP-mABs in patients with severe forms of migraine. To this end, the investigators will use an integrated hypothesis-based and data-driven, multidisciplinary approach that combines' omic testing in a deep-phenotyped migraine population and parallel fundamental research in a validated animal model of migraine. Three partners, Headache Science Centre, IRCCS C. Mondino Foundation, University of Pavia, Italy, Headache Research Group Vall d'Hebron Institute of Research, Barcelona, Spain and Institut für Systemische Neurowissenschaften, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany with an established long-standing and complementary expertise in neuroimaging, biochemical profiling and epigenetics in humans and in animal modeling of migraine will collaborate to achieve the Project's objective. The investigators expect important spin-offs to the improved management of migraine, both in terms of increased efficacy and cost saving, but also to understand CGRP-based mechanisms underlying migraine pathophysiology and to set the basis for a pathophysiologically driven classification. Healthcare providers and the pharmaceutical industry will be engaged once the biomarker(s) have been identified to optimize access to care and the use of resource, as well as to reduce disability and socio-economic impact of migraine.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 243 (tényleges)
- Első benyújtás
- 2020. aug. 3.
- Kezdés
- 2021. jan. 15.
- Elsődleges befejezés
- 2024. jan. 31.
- Fő szponzor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Betegségek
- Migrén
- NCT-szám
- NCT04503083
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 243
- 2021. jan. 15. és az elsődleges befejezés (2024. jan. 31.) között
- 3 helyszín, 3 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Medication overuse according to the ICHD-3 criteria.
- For the entire study population (migraine and healthy controls)
- 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;
- Concomitant use of other migraine preventive drugs that may interfere with the endpoints of the study.
Más betegség
- Presence of any other significant medical condition (neurological disorders, severe psychiatric illness or cardiovascular disease);
Egyéb
- For the clinical population:
- Headache on more than 25 days/month in the last 3 months;
- Pregnant or breastfeeding women;
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant who are not on contraception;
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 25 év – 55 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Institut für Systemische Neurowissenschaften, Universitätsklinikum Hamburg-Eppendorf | Hamburg | Németország | Ismeretlen állapot |
| Headache Research Group Vall d'Hebron Institute of Research | Barcelona | Spanyolország | Ismeretlen állapot |
| Headache Science Center | Pavia | Olaszország | Ismeretlen állapot |
Kapcsolódó publikációk
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