IRCCS National Neurological Institute "C. Mondino" Foundation — Biomedical Watch V2

Traitements17programmes

Essais10liés

Publications0liées

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Traitements

17

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
MAbsAim of the study was to assess a potential dysfunction of the endocannabidiome system (eCBome) in migraine patients. Migraine patients who will undergo preventive therapy with monoclonal antibodies directed against the calcitonin gene related peptide (mAbs) will be evaluated through a deep phenotyping of peripheral neurochemical biomarkers (eCBome, neuropeptides, cytokines and kynurenine levels, and microRNAs expression). Primary aim is to assess baseline differences among those patients who achieved a reduction of monthly migraine days \>/= 50% after three months of tretament (namely Responders) and those who did not (namely Non-responders).	Migraine	À vérifier	À vérifier	Italy	À vérifier
miR-155 Expression in Episodic and Chronic MigraineMigraine is a common, yet often disabling, neurological disease that affects over 1 billion people around the world. It's the second most disabling disease globally and the leading cause of disability for people under the age of 50, especially women. The effects of migraine aren't limited to the individual, with a tremendous economic impact on families, friends, and employers. To help reduce this burden, research is now focusing on developing biomarkers that can help with diagnosis, predicting response to treatments, and identifying those at risk of developing chronic migraine. MicroRNAs (miRNAs) are one of the most promising classes, as they can modulate gene expression and affect a wide range of cellular processes. Other studies have already observed different miRNA expression in those with episodic migraine or chronic migraine, but no specific miRNAs have been identified as a strong and specific migraine signature. miRNA-155 is of particular interest, as it has been linked to inflammation and pain, and may be a potential target for migraine treatments. It is known that the immune system plays a role in migraine headaches. Monocytes, a type of immune cell, may be involved in the development of migraines. Certain medicines, such as aspirin, can affect monocyte function and have been used to treat migraines. Recent research has also shown that microRNAs can regulate the activity of these cells and influence inflammation, which may be linked to migraine attacks. This study aims to investigate the role of miRNA-155 and monocyte differentiation in migraine patients, and in particular its association with migraine phenotype and severity. We aim to study three groups of subjects: Episodic migraine (EM), Chronic migraine with or without Medication Overuse Headache (CM-MOH) and Healthy Controls (HCs).	Migraine	À vérifier	Immunomodulation + Traitement symptomatique	Italy	À vérifier
Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs)Migraine is a leading cause of disability with an estimated prevalence of 12% in Europe. The headache field witnessed a breakthrough since the introduction of specific preventive therapies which proved effective and well tolerated, namely the monoclonal antibodies directed against the Calcitonin Gene Related Peptide (CGRP) pathway (mAbs). Their mechanism of action is still debated. Several Authors claimed that, despite the site of action is peripheral (namely outside of the blood brain barrier), the resulting action may take place at central level. Another valuable hypothesis is that the clinical modifications resulting from mAbs treatment may induce functional modulation of several brain areas. With these premises, the primary aim of the study is to evaluate changes in functional connectivity in patients undergoing preventive mAbs treatment using high density EEG.	Migraine	À vérifier	À vérifier	Italy	À vérifier
Non-Invasive Brain Stimulation as Add-on Treatment in Chronic Migraine With Medication OveruseThis randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy of non-invasive brain stimulation as an add-on treatment to standard detoxification therapy in patients with chronic migraine and medication overuse. The study also seeks to identify sensory and biochemical biomarkers predictive of treatment response.	Migraine	Non applicable	À vérifier	Italy	À vérifier
Pain Control in Episodic and Chronic MigraineThe phenomenon of offset analgesia (OA) refers to a disproportionately large decrease in perceived pain following a slight reduction in the intensity of a noxious heat stimulus. This phenomenon is considered as an indicator of the activation of the endogenous pain modulation system, whose dysfunction is implicated in the pathophysiology of migraine and other chronic pain conditions. This study aims to investigate pain processing mechanisms using the OA paradigm in individuals with episodic migraine (EM) during different phases of the migraine cycle and in those with chronic migraine (CM), with and without medication overuse headache (CMwoMOH and CM-MOH, respectively). A population of healthy subjects matched by sex and age will also be enrolled	Migraine	Non applicable	Traitement symptomatique	Italy	À vérifier
Psychological and Biological Markers of Refractory MigraineThe term "refractory" migraine describes a particularly aggressive form of the disease in which the patient does not benefit from any of the preventive therapies with the various classes of drugs available, including treatment with monoclonal antibodies directed against Calcitonin Gene Related Peptide (CGRP). Anxiety, depressive symptoms, somatization, and pain hypersensitivity are significantly more prevalent in refractory migraineurs than in non-refractory subjects who benefit from preventive therapies, suggesting that these symptoms may contribute to treatment refractoriness. Recently, in a preliminary study on the efficacy of a CGRP-targeting monoclonal antibody in Chronic Migraine (CM) patients with at least 3 failures to previous preventive treatments, the investigators showed a higher prevalence of psychological disturbances in those who did respond to the monoclonal antibody compared with the responders. These data, although preliminary, point to a more psychologically complicated picture in non-responder patients compared with responders. To date, however, no neurobiological evaluations are available to explain how psychological comorbidities may contribute to treatment refractoriness. Isolated clinical evidence and growing pre-clinical evidence suggests a role for the endocannabinoid system in migraine. Hence, the present study aims to identify psychological and biological factors associated with refractory migraine. The investigators' hypothesis is that patients presenting with psychological disorders may bear an associated dysfunction of the endocannabinoid system, which makes them more resistant to migraine preventive therapies, including monoclonal antibodies directed against CGRP.	Migraine	À vérifier	Traitement symptomatique	Italy	À vérifier
SPHERA_WP2 — Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to TreatmentsPrimary working hypothesis is that NON-responders to mAbs bear a dysfunction of the endocannabidiome system (eCBome), as suggested by pre-clinical and clinical data by our group. They will be identified as patients showing a reduction of monthly migraine days \< 50% after three months of treatment. The clinical, biochemical and neurofunctional impact of novel therapeutic approaches expected to interfere with eCBome will be evaluated in NON-responder patients	Migraine	À vérifier	À vérifier	Italy	À vérifier
The Possible Neuroprotective Effect of Ocrelizumab Via VEGF Protein Expression in Relapsing Multiple Sclerosis PatientsOcrelizumab (OCR) is a humanized anti-CD20 antibody approved for Relapsing Multiple Sclerosis (RMS) and Primary Progressive Multiple Sclerosis (PPMS), due to neuroprotective effects of partially unknown origin. While its mechanism of action is mainly thought to occur via B cell depletion, previous studies on rituximab, another anti-CD20 drug, showed that CD20 binding elicits several intracellular signalling pathways, also including Protein Kinase C (PKC) activation. Of interest, the β isoform of PKC is known to modulate, through the RNA-binding protein ELAV/HuR, the expression of Vascular Endothelial Growth Factor (VEGF), a signaling protein that has been suggested to play deleterious effects in the first phases of MS. Therefore, the hypothesis is that part of the neuroprotective effects exerted by OCR may also be due to the modulation of VEGF expression via PKCβ /HuR cascade. The primary objective is to evaluate the variation of the expression of VEGF (protein and mRNA) in Peripheral Blood Mononuclear Cells (PBMCs) induced by OCR therapy. No additional visits will be required outside of clinical practice. Additional laboratory testing (VEGF protein expression and PKCbeta/HuR cascade) will be performed on extra blood which will be taken during the routine blood exams. This study is an observational, longitudinal, monocenter and single arm study, in patients with RMS who are newly prescribed with OCR as per clinical practice. The study consists of the following visits as per clinical practice * T0 visit: at the first dose of OCR, blood sample and clinical/radiological MS data will be collected. * T6: after 6 months of OCR treatment, blood samples and clinical MS data will be collected. * T12 visit: after 12 months of OCR treatment, blood samples and clinical MS data will be collected.	SEP	À vérifier	Immunomodulation		À vérifier
Psychological and Biological Markers of Refractory MigraineThe term "refractory" migraine describes a particularly aggressive form of the disease in which the patient does not benefit from any of the preventive therapies with the various classes of drugs available, including treatment with monoclonal antibodies directed against Calcitonin Gene Related Peptide (CGRP). Anxiety, depressive symptoms, somatization, and pain hypersensitivity are significantly more prevalent in refractory migraineurs than in non-refractory subjects who benefit from preventive therapies, suggesting that these symptoms may contribute to treatment refractoriness. Recently, in a preliminary study on the efficacy of a CGRP-targeting monoclonal antibody in Chronic Migraine (CM) patients with at least 3 failures to previous preventive treatments, the investigators showed a higher prevalence of psychological disturbances in those who did respond to the monoclonal antibody compared with the responders. These data, although preliminary, point to a more psychologically complicated picture in non-responder patients compared with responders. To date, however, no neurobiological evaluations are available to explain how psychological comorbidities may contribute to treatment refractoriness. Isolated clinical evidence and growing pre-clinical evidence suggests a role for the endocannabinoid system in migraine. Hence, the present study aims to identify psychological and biological factors associated with refractory migraine. The investigators' hypothesis is that patients presenting with psychological disorders may bear an associated dysfunction of the endocannabinoid system, which makes them more resistant to migraine preventive therapies, including monoclonal antibodies directed against CGRP.	Migraine	À vérifier	Traitement symptomatique	Italy	À vérifier
Non-Invasive Brain Stimulation as Add-on Treatment in Chronic Migraine With Medication OveruseThis randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy of non-invasive brain stimulation as an add-on treatment to standard detoxification therapy in patients with chronic migraine and medication overuse. The study also seeks to identify sensory and biochemical biomarkers predictive of treatment response.	Migraine	Non applicable	À vérifier	Italy	À vérifier
Pain Control in Episodic and Chronic MigraineThe phenomenon of offset analgesia (OA) refers to a disproportionately large decrease in perceived pain following a slight reduction in the intensity of a noxious heat stimulus. This phenomenon is considered as an indicator of the activation of the endogenous pain modulation system, whose dysfunction is implicated in the pathophysiology of migraine and other chronic pain conditions. This study aims to investigate pain processing mechanisms using the OA paradigm in individuals with episodic migraine (EM) during different phases of the migraine cycle and in those with chronic migraine (CM), with and without medication overuse headache (CMwoMOH and CM-MOH, respectively). A population of healthy subjects matched by sex and age will also be enrolled	Migraine	Non applicable	Traitement symptomatique	Italy	À vérifier
MAbsAim of the study was to assess a potential dysfunction of the endocannabidiome system (eCBome) in migraine patients. Migraine patients who will undergo preventive therapy with monoclonal antibodies directed against the calcitonin gene related peptide (mAbs) will be evaluated through a deep phenotyping of peripheral neurochemical biomarkers (eCBome, neuropeptides, cytokines and kynurenine levels, and microRNAs expression). Primary aim is to assess baseline differences among those patients who achieved a reduction of monthly migraine days \>/= 50% after three months of tretament (namely Responders) and those who did not (namely Non-responders).	Migraine	À vérifier	À vérifier	Italy	À vérifier
SPHERA_WP2 — Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to TreatmentsPrimary working hypothesis is that NON-responders to mAbs bear a dysfunction of the endocannabidiome system (eCBome), as suggested by pre-clinical and clinical data by our group. They will be identified as patients showing a reduction of monthly migraine days \< 50% after three months of treatment. The clinical, biochemical and neurofunctional impact of novel therapeutic approaches expected to interfere with eCBome will be evaluated in NON-responder patients	Migraine	À vérifier	À vérifier	Italy	À vérifier
MAbsAim of the study was to assess a potential dysfunction of the endocannabidiome system (eCBome) in migraine patients. Migraine patients who will undergo preventive therapy with monoclonal antibodies directed against the calcitonin gene related peptide (mAbs) will be evaluated through a deep phenotyping of peripheral neurochemical biomarkers (eCBome, neuropeptides, cytokines and kynurenine levels, and microRNAs expression). Primary aim is to assess baseline differences among those patients who achieved a reduction of monthly migraine days \>/= 50% after three months of tretament (namely Responders) and those who did not (namely Non-responders).	Migraine	À vérifier	À vérifier	Italy	À vérifier
Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs)Migraine is a leading cause of disability with an estimated prevalence of 12% in Europe. The headache field witnessed a breakthrough since the introduction of specific preventive therapies which proved effective and well tolerated, namely the monoclonal antibodies directed against the Calcitonin Gene Related Peptide (CGRP) pathway (mAbs). Their mechanism of action is still debated. Several Authors claimed that, despite the site of action is peripheral (namely outside of the blood brain barrier), the resulting action may take place at central level. Another valuable hypothesis is that the clinical modifications resulting from mAbs treatment may induce functional modulation of several brain areas. With these premises, the primary aim of the study is to evaluate changes in functional connectivity in patients undergoing preventive mAbs treatment using high density EEG.	Migraine	À vérifier	À vérifier	Italy	À vérifier
miR-155 Expression in Episodic and Chronic MigraineMigraine is a common, yet often disabling, neurological disease that affects over 1 billion people around the world. It's the second most disabling disease globally and the leading cause of disability for people under the age of 50, especially women. The effects of migraine aren't limited to the individual, with a tremendous economic impact on families, friends, and employers. To help reduce this burden, research is now focusing on developing biomarkers that can help with diagnosis, predicting response to treatments, and identifying those at risk of developing chronic migraine. MicroRNAs (miRNAs) are one of the most promising classes, as they can modulate gene expression and affect a wide range of cellular processes. Other studies have already observed different miRNA expression in those with episodic migraine or chronic migraine, but no specific miRNAs have been identified as a strong and specific migraine signature. miRNA-155 is of particular interest, as it has been linked to inflammation and pain, and may be a potential target for migraine treatments. It is known that the immune system plays a role in migraine headaches. Monocytes, a type of immune cell, may be involved in the development of migraines. Certain medicines, such as aspirin, can affect monocyte function and have been used to treat migraines. Recent research has also shown that microRNAs can regulate the activity of these cells and influence inflammation, which may be linked to migraine attacks. This study aims to investigate the role of miRNA-155 and monocyte differentiation in migraine patients, and in particular its association with migraine phenotype and severity. We aim to study three groups of subjects: Episodic migraine (EM), Chronic migraine with or without Medication Overuse Headache (CM-MOH) and Healthy Controls (HCs).	Migraine	À vérifier	Immunomodulation + Traitement symptomatique	Italy	À vérifier
The Possible Neuroprotective Effect of Ocrelizumab Via VEGF Protein Expression in Relapsing Multiple Sclerosis PatientsOcrelizumab (OCR) is a humanized anti-CD20 antibody approved for Relapsing Multiple Sclerosis (RMS) and Primary Progressive Multiple Sclerosis (PPMS), due to neuroprotective effects of partially unknown origin. While its mechanism of action is mainly thought to occur via B cell depletion, previous studies on rituximab, another anti-CD20 drug, showed that CD20 binding elicits several intracellular signalling pathways, also including Protein Kinase C (PKC) activation. Of interest, the β isoform of PKC is known to modulate, through the RNA-binding protein ELAV/HuR, the expression of Vascular Endothelial Growth Factor (VEGF), a signaling protein that has been suggested to play deleterious effects in the first phases of MS. Therefore, the hypothesis is that part of the neuroprotective effects exerted by OCR may also be due to the modulation of VEGF expression via PKCβ /HuR cascade. The primary objective is to evaluate the variation of the expression of VEGF (protein and mRNA) in Peripheral Blood Mononuclear Cells (PBMCs) induced by OCR therapy. No additional visits will be required outside of clinical practice. Additional laboratory testing (VEGF protein expression and PKCbeta/HuR cascade) will be performed on extra blood which will be taken during the routine blood exams. This study is an observational, longitudinal, monocenter and single arm study, in patients with RMS who are newly prescribed with OCR as per clinical practice. The study consists of the following visits as per clinical practice * T0 visit: at the first dose of OCR, blood sample and clinical/radiological MS data will be collected. * T6: after 6 months of OCR treatment, blood samples and clinical MS data will be collected. * T12 visit: after 12 months of OCR treatment, blood samples and clinical MS data will be collected.	SEP	À vérifier	Immunomodulation		À vérifier

Essais cliniques

10

Molécule	Indication / population	Phase	NCT	Titre	Statut
The Possible Neuroprotective Effect of Ocrelizumab Via VEGF Protein Expression in Relapsing Multiple Sclerosis Patients	SEP	À vérifier	NCT04902690	The Possible Neuroprotective Effect of Ocrelizumab Via VEGF Protein Expression in Relapsing Multiple Sclerosis Patients	UNKNOWN
miR-155 Expression in Episodic and Chronic Migraine	Migraine	À vérifier	NCT05891808	miR-155 Expression in Episodic and Chronic Migraine	UNKNOWN
Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs)	Migraine	À vérifier	NCT06155123	HD-EEG Connectivity Changes in Migraine Patients Undergoing Treatment With Anti-CGRP mAbs	UNKNOWN
MAbs	Migraine	À vérifier	NCT06562413	SPHERA_WP1_2 — Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments	RECRUITING
SPHERA_WP2 — Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments	Migraine	À vérifier	NCT06562400	SPHERA_WP2 — Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments	RECRUITING
MAbs	Migraine	À vérifier	NCT06549270	SPHERA_WP1_1 — Biochemical Profiling of Migraine Patients	RECRUITING
Pain Control in Episodic and Chronic Migraine	Migraine	Non applicable	NCT06599905	Pain Control in Episodic and Chronic Migraine	COMPLETED
Atogepant 60 mg	Migraine	À vérifier	NCT06882122	ATOM — Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine	RECRUITING
Non-Invasive Brain Stimulation as Add-on Treatment in Chronic Migraine With Medication Overuse	Migraine	Non applicable	NCT07442916	Non-Invasive Brain Stimulation as Add-on Treatment in Chronic Migraine With Medication Overuse	COMPLETED
Psychological and Biological Markers of Refractory Migraine	Migraine	À vérifier	NCT05046119	Psychological and Biological Markers of Refractory Migraine	UNKNOWN

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.