Actively Recruiting
Biochemical Profiling of Migraine Patients
Led by IRCCS National Neurological Institute "C. Mondino" Foundation · Updated on 2024-09-05
100
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
I
IRCCS National Neurological Institute "C. Mondino" Foundation
Lead Sponsor
U
University of L'Aquila
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Biochemical Profiling of Migraine Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 failure of at least 3 classes of migraine preventatives and at least 8 debilitating monthly headache days for at least 3 consecutive months
- Patients who have not previously received CGRP-targeting treatments
You will not qualify if you...
- History of major psychiatric or other neurological conditions
- Diagnosis of other primary or secondary headache disorders (sporadic tension-type headache allowed if clearly differentiated)
- Changes in ongoing preventive treatment within the previous 3 months
- Clinically significant medical conditions
- Chronic pain conditions
- Alcohol and/or drug abuse
- Pregnancy or lactation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Headache Science & Neurorehabilitation Unit
Pavia, Italy, 27100
Actively Recruiting
Research Team
R
Roberto De Icco
CONTACT
C
Cinzia Fattore
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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