Biochemical Profiling of Migraine Patients
NCT Number: NCT06549270
Acronym: SPHERA_WP1_1
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Migraine Disorders|Chronic Migraine|Episodic Migraine
Interventions: DRUG: MAbs
Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborators: University of L'Aquila
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-10
Completion Date: 2026-05
Locations: Headache Science & Neurorehabilitation Unit, Pavia, 27100, Italy

Summary:
Aim 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).

Primary Outcome Measures: Gene expression of FAAH, Baseline differences in gene expression of fatty acid amide hydrolase (FAAH) in peripheral blood mononuclear cells (PBMC) (continuous variable), Baseline (T0) - three months of mAbs treatment (T1)|Gene expression of MAGL, Gene expression of Monoacylglycerol lipase (MAGL) in peripheral blood mononuclear cells (PBMC) (continuous variable), Baseline (T0) - three months of mAbs treatment (T1)
Secondary Outcome Measures: Gene expression of catalyzing enzymes (DAGL, NAPE, NAAA), Gene expression of diacylglycerol lipase (DAGL), N-acylphosphatidyl ethanolamide (NAPE) and N-acylethanolamine acid amidohydrolase (NAAA) in peripheral blood mononuclear cells (PBMC) (continuous variable), Baseline (T0) - three months of mAbs treatment (T1)|Plasma levels of AEA, 2-AG, PEA, OEA, Plasma levels of endocannabinoids and related lipids (N-arachidonoyl ethanolamide (AEA), 2-arachidonoyl glycerol (2-AG), PEA and anorexigenic oleoyl ethanolamide (OEA (continuous variable), Baseline (T0) - three months of mAbs treatment (T1)|Plasma levels of CGRP, PACAP and VIP, Plasma levels of neuropeptides: calcitonin gene related pepetide (CGRP), pituitary adenylate cyclase-activating peptide (PACAP), vasoactive intestinal peptide (VIP) (continuous variable), Baseline (T0) - three months of mAbs treatment (T1)|Gene expression of miR-382-5p, miR-34a, miR-30a and miR-155, microRNAs gene expression (specifically miR-382-5p, miR-34a, miR-30a and miR-155) in peripheral blood mononuclear cells (PBMC) (continuous variable), Baseline (T0) - three months of mAbs treatment (T1)|Plasma levels of IL-1beta, TNF-alpha, IL-4 and IL-10, Plasma levels of proinflammatory (IL-1beta, TNF-alpha) and anti-inflammatory cytokines (IL-4 and IL-10) (continuous variables), Baseline (T0) - three months of mAbs treatment (T1)|Plasma levels of kynurenic acid and quinolinic acid, Plasma levels of kynurenine metabolites (continuous variables), Baseline (T0) - three months of mAbs treatment (T1)|Shotgun analysis of microbiota, Shotgun analysis of microbiota in patients' faeces, Baseline (T0) - three months of mAbs treatment (T1)