Status:
RECRUITING
Biochemical Profiling of Migraine Patients
Lead Sponsor:
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborating Sponsors:
University of L'Aquila
Conditions:
Migraine Disorders
Chronic Migraine
Eligibility:
All Genders
18-75 years
Brief 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 di...
Detailed Description
Previous evidence showed that endocannabidiome system (eCBome) is altered in migraine patients demonstrating: i) altered gene expression of catabolizing enzymes (MAGL and FAAH) in patients with episod...
Eligibility Criteria
Inclusion
- 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
- patients naive to CGRP targeting treatments
Exclusion
- 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
- chronic pain conditions
- alcohol and/or drug abuse
- pregnancy or lactation
Key Trial Info
Start Date :
May 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06549270
Start Date
May 10 2023
End Date
May 1 2026
Last Update
September 5 2024
Active Locations (1)
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1
Headache Science & Neurorehabilitation Unit
Pavia, Italy, 27100