Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments
Recruiting · NCT06562400 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
View the official record on ClinicalTrials.gov →Interventions studied
Ketogenic dietPalmitoyl ethanolamide
What this trial is about
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 can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Headache Science & Neurorehabilitation Unit - Pavia, Italy