NCT04503083Completed
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
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 243 (actual)
- First submitted
- 3 Aug 2020
- Start date
- 15 Jan 2021
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Diseases
- Migraine
- NCT number
- NCT04503083
What you commit to
- Study type: Observational
- Participants enrolled: 243
- From 15 Jan 2021 to the primary completion date, 31 Jan 2024
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Presence of any other significant medical condition (neurological disorders, severe psychiatric illness or cardiovascular disease);
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 25 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut für Systemische Neurowissenschaften, Universitätsklinikum Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Headache Research Group Vall d'Hebron Institute of Research Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Headache Science Center Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.