Biochemical Profiling of Migraine Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
male and female patients aged 18 to 75 years
diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria
for episodic migraine: 8-14 monthly migraine days in the previous 3 months
diagnosis of resistant migraine defined by: i) having failed at least 3 classes of migraine preventatives and ii) suffering from at least 8 debilitating monthly headache days for at least 3 consecutive months
Disqualifiers
history of major psychiatric or other neurological conditions
diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches)
changes in ongoing preventive treatment (if any) in the previous 3 months
clinically significant medical conditions
Trial population
Subjects with chronic or high frequency episodic migraine attending the outpatient clinic of the Headache Science \& Neurorehabilitation Unit of the IRCCS Mondino Foundation (Pavia, Italy) and the Neurology Department of the University of L'Aquila (Avezzano, Italy).
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
MAbs
DrugMonthly or quarterly mAbs administration
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Responders1 intervention
Group B: Non-Responders1 intervention
Trial outcomes
Primary outcomes
1
Gene expression of FAAH
Baseline differences in gene expression of fatty acid amide hydrolase (FAAH) in peripheral blood mononuclear cells (PBMC) (continuous variable)
Time frame
Baseline (T0) - three months of mAbs treatment (T1)2
Gene expression of MAGL
Gene expression of Monoacylglycerol lipase (MAGL) in peripheral blood mononuclear cells (PBMC) (continuous variable)
Time frame
Baseline (T0) - three months of mAbs treatment (T1)Secondary outcomes
1
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)
Time frame
Baseline (T0) - three months of mAbs treatment (T1)2
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)
Time frame
Baseline (T0) - three months of mAbs treatment (T1)3
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)
Time frame
Baseline (T0) - three months of mAbs treatment (T1)4
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)
Time frame
Baseline (T0) - three months of mAbs treatment (T1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS National Neurological Institute "C. Mondino" Foundation
Lead sponsor
University of L'Aquila
Collaborator
Source ClinicalTrials.gov