BIOmarkers of MIGraine: a Proof of Concept Study Based on the Stratification of Responders to CGRP Monoclonal Antibodies (BIOMIGA)
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|ClinicalTrials.gov Identifier: NCT04503083|
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : April 29, 2021
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||219 participants|
|Official Title:||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|
|Actual Study Start Date :||January 15, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||March 1, 2023|
- Biomarkers and CGRP-targeting mABs [ Time Frame: Day 0 and Week 12 ]To identify a computational algorithm using a machine learning approach based on different types of biomarkers (demographic, clinical, psychological, cognitive, epigenetic, pharmacogenetic, biochemical and structural & functional brain imaging) that is predictive of response to the class of the CGRP-targeting mABs.
- Methylation levels [ Time Frame: Day 0 and Week 12 ]Difference in methylation levels in migraine subjects as compared to healthy controls
- Brain morphometric measures [ Time Frame: Day 0 and Week 12 ]Differences in brain morphometric measures between migraine patients and healthy controls at the neuroanatomic and neurofunctional levels
- Pharmacogenetic, biochemical, clinical and psychological markers [ Time Frame: Day 0 and Week 12 ]Differences in pharmacogenetic, biochemical, clinical and psychological markers between migraine patients and healthy controls
- Methylation levels at the neuroanatomic and neurofunctional levels [ Time Frame: Day 0 and Week 12 ]Difference in methylation levels in migraine subjects between migraine patients and healthy controls at the neuroanatomic and neurofunctional levels
- Morphometric measures [ Time Frame: Day 0 and Week 12 ]Differences in brain morphometric measures between migraine subjects who are responder and those who are non responders to CGRP-targeting mABs
- Pharmacogenetic, biochemical, clinical and psychological markers in responder and non responders [ Time Frame: Day 0 and Week 12 ]Differences in pharmacogenetic, biochemical, clinical and psychological between migraine subjects who are responder and those who are non responders to CGRP-targeting mABs
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503083
|Contact: Cristina Tassorelli, MD||0039 382 firstname.lastname@example.org|
|Contact: Cinzia Fattore, MD||0039 email@example.com|
|Institut für Systemische Neurowissenschaften, Universitätsklinikum Hamburg-Eppendorf||Not yet recruiting|
|Hamburg, Germany, 20357|
|Contact: Arne May, MD firstname.lastname@example.org|
|Headache Science Center||Recruiting|
|Pavia, Italy, 27100|
|Contact: Cristina Tassorelli, MD 0382380390 email@example.com|
|Contact: Daniele Martinelli, MD 0382 380390 firstname.lastname@example.org|
|Headache Research Group Vall d'Hebron Institute of Research||Not yet recruiting|
|Barcelona, Cataluna, Spain, 8009|
|Contact: Patricia Pozo-Rosich, MD email@example.com|
|Principal Investigator:||Cristina Tassorelli, Prof||IRCCS Mondino Foundation, Pavia|