RECRUITINGOBSERVATIONAL

Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments

Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - patients naive to CGRP targeting treatments Who Should NOT Join This Trial: - 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 - alcohol and/or drug abuse - pregnancy or lactation Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 * patients naive to CGRP targeting treatments Exclusion Criteria: * 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 * alcohol and/or drug abuse * pregnancy or lactation

Treatments Being Tested

DIETARY_SUPPLEMENT

Palmitoyl ethanolamide

PEA supplementation (600mg twice a day for three months)

BEHAVIORAL

Ketogenic diet

Diet characterized by the following percentages of macronutrients: 65% fat, 27% protein and 8% carbohydrates

Locations (1)

Headache Science & Neurorehabilitation Unit

Pavia, Italy