Primary working hypothesis is that NON-responders to mAbs bear a dysfunction of the endocannabidiome system (eCBome), as suggested by pre-clinical and clinical data by our group.
They will be identified as patients showing a reduction of monthly migraine days \< 50% after three months of treatment.
The clinical, biochemical and neurofunctional impact of novel therapeutic approaches expected to interfere with eCBome will be evaluated in NON-responder patients
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 having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating monthly headache days for at least 3 consecutive months
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)
clinically significant medical conditions
chronic pain conditions
IRCCS National Neurological Institute "C. Mondino" Foundation
Lead sponsor
University of L'Aquila
Collaborator