Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT05313503
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-65 years old
* Chronic migraine, diagnosed according to ICHD-3 criteria.
* Patients with resistant form of migraine defined as: persistence of 8 days of headache per month; therapeutic failure (after therapeutic treatment of adequate dose and duration) or contraindication of 3 classes of drugs with validated evidence of efficacy in the prevention of migraine.
* Non-responder (absence of reduction of MIDAS score of at least 50% after at least 3 months of treatment) to at least one anti-CGRP monoclonal antibody
* Absence of prophylactic therapies for migraine or prophylaxis therapy with a single drug taken at a stable dose for at least two months
* BMI \> 16.5 kg/m2 and \< 35 kg/m2
* Hypothesized compliance in filling the headache diary and following the prescribed diet
Exclusion Criteria:
* Kidney failure
* Liver failure
* Heart failure
* Recent heart attack
* Pancreatitis
* Alcoholism
* Severe osteoporosis
* Other neurological disorders, including other forms of primary headache, except sporadic episodic tension-type headache
* Diabetes Mellitus
* Severe lipid metabolism disorders
* Women of childbearing age without active contraception
* Pregnancy or breastfeeding
* Psychiatric disorders that the clinician thinks may interfere with patient compliance / eating disorders
* Other anomalies considered significant in preliminary examinations (blood tests and EKG)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05313503
Study Brief:
Protocol Section:
NCT05313503