KETOMIGRAINE: Ketogenic Diet in Drug-resistant Chronic Migraineurs
Italy20 participantsStarted 2022-01-14
Plain-language summary
Our protocol, named "KETOMIGRAINE", is based on the prescription of a Ketogenic Diet (KD) to twenty subjects with diagnosis of Chronic Migraine (CM), resistant to oral preventive treatments and non-responders to monoclonal antibodies targeting the CGRP pathway. The trial starts with one month of baseline during which are verified inclusion/exclusion criteria. After that, participants will assume KD for three months, a transitional diet (TD) for other three months. Follows a period of three months of free diet (FD). Neurological and dietician visits are scheduled during the course of the trial.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of mean monthly migraine days
Timeframe: During the 3 months of Ketogenic diet period
Trial details
NCT IDNCT05313503
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation