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RECRUITING
NCT06562400

Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments

Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

45

Start Date

2023-05-10

Completion Date

2026-05

Last Updated

2024-08-20

Healthy Volunteers

Not specified

Interventions

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