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Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments

NCT06562400 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2024-08-20

No results posted yet for this study

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

Conditions

  • Migraine Disorders
  • Chronic Migraine
  • Episodic Migraine

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

Sponsors & Collaborators

  • University of L'Aquila

    collaborator OTHER

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2024-10-31
Completion
2026-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06562400 on ClinicalTrials.gov