KETOMIGRAINE: Ketogenic Diet in Drug-resistant Chronic Migraineurs

NCT05313503 | Unknown

• 1 other identifier: KETOMIGRAINE2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Chronic Migraine, Headache

Keywords

Ketogenic Diet; reistant migraine; CGRP; headache; pain

Outcome Measures

Primary Outcomes (1)

• Change of mean monthly migraine days

  The primary endpoint is the change of mean monthly migraine days during the treatment phase compared to the baseline period. The number of migraine days will be established by the analysis of the headache diary that the patients are required to fill in for the duration of the study

  During the 3 months of Ketogenic diet period

Secondary Outcomes (12)

• Change of number of headache day per month

  Through study completion, an average of 10 months

• Change of doses of symptomatic drug intake per month

  Through study completion, an average of 10 months

• Change of number of days of moderate to severe headache

  Through study completion, an average of 10 months

• Change of days of symptomatic drug intake per month

  Through study completion, an average of 10 months

• Change of average pain intensity

  Through study completion, an average of 10 months

Other Outcomes (1)

• Effect of KD in the subgroups identified by the type of diet (normal-calorie and low-calorie diet)

  Through study completion, an average of 10 months

Study Arms (1)

Ketogenic Diet

EXPERIMENTAL

Ketogenic diet

Other: ketogenic diet

Interventions

ketogenic diet OTHER

We propose a type of KD named MAD (Modified Atkins Diet) characterized by the following percentages of macronutrients: 65% fats, 27% proteins and 8% carbohydrates.

Ketogenic Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

Headache Science Center

Pavia, 27100, Italy

RECRUITING

Related Publications (3)

• de Almeida Rabello Oliveira M, da Rocha Ataide T, de Oliveira SL, de Melo Lucena AL, de Lira CE, Soares AA, de Almeida CB, Ximenes-da-Silva A. Effects of short-term and long-term treatment with medium- and long-chain triglycerides ketogenic diet on cortical spreading depression in young rats. Neurosci Lett. 2008 Mar 21;434(1):66-70. doi: 10.1016/j.neulet.2008.01.032. Epub 2008 Jan 19.

  PMID: 18281154 BACKGROUND

• Di Lorenzo C, Coppola G, Sirianni G, Di Lorenzo G, Bracaglia M, Di Lenola D, Siracusano A, Rossi P, Pierelli F. Migraine improvement during short lasting ketogenesis: a proof-of-concept study. Eur J Neurol. 2015 Jan;22(1):170-7. doi: 10.1111/ene.12550. Epub 2014 Aug 25.

  PMID: 25156013 RESULT

• Bongiovanni D, Benedetto C, Corvisieri S, Del Favero C, Orlandi F, Allais G, Sinigaglia S, Fadda M. Effectiveness of ketogenic diet in treatment of patients with refractory chronic migraine. Neurol Sci. 2021 Sep;42(9):3865-3870. doi: 10.1007/s10072-021-05078-5. Epub 2021 Feb 1.

  PMID: 33527209 RESULT

MeSH Terms

Conditions

Headache; Pain

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Cristina Tassorelli, Prof

  IRCCS Mondino Foundation, Pavia

  STUDY DIRECTOR

Central Study Contacts

Marta Allena, MD

CONTACT

+390382380207; marta.allena@mondino.it

Lara Ahmad, MD

CONTACT

+390382380390; lara.ahmad@mondino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: interventional, monocentric, open label

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 6, 2022
• Study Start: January 14, 2022
• Primary Completion: January 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)