Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06562400

Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments

Led by IRCCS National Neurological Institute "C. Mondino" Foundation · Updated on 2024-08-20

45

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

Sponsors

I

IRCCS National Neurological Institute "C. Mondino" Foundation

Lead Sponsor

U

University of L'Aquila

Collaborating Sponsor

AI-Summary

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

CONDITIONS

Official Title

Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients aged 18 to 75 years
  • Diagnosis of episodic 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 failure of at least 3 classes of migraine preventatives and at least 8 disabling monthly headache days for 3 consecutive months
  • Patients who have not previously received CGRP targeting treatments
Not Eligible

You will not qualify if you...

  • History of major psychiatric or other neurological conditions
  • Diagnosis of other primary or secondary headache disorders except sporadic tension-type headache if distinguishable
  • Clinically significant medical conditions
  • Chronic pain conditions
  • Alcohol or drug abuse
  • Pregnancy or lactation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Headache Science & Neurorehabilitation Unit

Pavia, Italy, 27100

Actively Recruiting

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Research Team

R

Roberto De Icco

CONTACT

C

Cinzia Fattore

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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