Status:
UNKNOWN
KETOMIGRAINE: Ketogenic Diet in Drug-resistant Chronic Migraineurs
Lead Sponsor:
IRCCS National Neurological Institute "C. Mondino" Foundation
Conditions:
Chronic Migraine, Headache
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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-re...
Detailed Description
The duration of the trial for individual participants is approximately 10 months, divided as follows: 1 month of baseline + 3 months of KD + 3 months of TD+ 3 months of follow-up. The protocol includ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05313503
Start Date
January 14 2022
End Date
November 30 2023
Last Update
April 6 2022
Active Locations (1)
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1
Headache Science Center
Pavia, Italy, 27100