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
Qualifiers
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 design
Treatments tested in this trial
- MAbs
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
Lead sponsor
University of L'Aquila
Collaborator
Source ClinicalTrials.gov