KETOMIGRAINE: Ketogenic Diet in Drug-resistant Chronic Migraineurs
Unknown statusNot applicableNCT05313503
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- KETOMIGRAINE: "Ketogenic Diet in Patients With Drug-resistant Chronic Migraine, "Non-responder" to Treatment With Monoclonal Antibody Targetting CGRP Pathway: a Pilot Study, Open Label"
- Conditions
- Interventions
- Other: ketogenic diet
- Sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Start date
- 2022-01-14
- Primary completion
- 2023-01-30
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05313503