Management of Drug-resistant Epilepsy in Infants and Children: a Real-life Study of the Use of th… (NCT06075485) | Clinical Trial Compass
UnknownNot Applicable
Management of Drug-resistant Epilepsy in Infants and Children: a Real-life Study of the Use of the Ketogenic Diet in France and the KetoCal® Range in Its Maintenance
France133 participantsStarted 2024-01-15
Plain-language summary
This is a multicenter, prospective, observational, longitudinal study designed to describe the therapeutic value of the KetoCal® range in the maintenance of a ketogenic diet during the management of infants (from 5 months) and children up to 17 years of age (i.e. 18 years minus 1 day) with drug-resistant epilepsy.
This study is being conducted according to standard medical practice. No change in diagnostic or therapeutic management habits is imposed by this study. Quality of life questionnaires are the only additional procedures for this research.
Who can participate
Age range
5 Months – 18 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:
* Infants from 5 months and children up to 17 years of age (maximum 18 years minus 1 day).
* With drug-resistant epilepsy according to ILAE (International League Against Epilepsy) criteria: persistence of epileptic seizures after failure of two appropriate antiepileptic drugs tried consecutively or in well-tolerated combination.
* Indication for CR by a physician.
* Parents (or legal guardians) able to set up and follow the diet, assessed during a joint doctor-dietician consultation.
* Written authorization from one (or both) parents or the child's legal representative to collect personal information about their child.
* Affiliation of the infant/child with the social security system.
Exclusion Criteria:
* Contraindication to ketogenic diet at initial assessment.
* Children already on a ketogenic diet.
* Parenteral nutrition.
* Concurrent prescription of other foodstuffs intended for special medical purposes (DADFMS) such as KetoVie or Keyo.
* Protected legal representative (under legal protection, or deprived of liberty by judicial or administrative decision).
* Legal representative not covered by a social security scheme.
* Legal representative unable to understand study protocol.
Ancillary study eligibility criteria :
* Patients included in the study.
* Continued on the ketogenic diet for at least 2 months.
* Having consented to participate in the ancillary study.
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.
1This study is focused on observing how well children actually stick to the ketogenic diet in real life — can you tell me how demanding the ketogenic diet would be for my child's daily routine, and whether our family is realistically set up to manage it?
2Since this is a real-world observational study in France rather than a controlled trial testing a new treatment, would participating in it change anything about my child's actual medical care, or would they simply receive the ketogenic diet as they normally would?
3The study involves a specific medical food product called KetoCal® for maintaining the ketogenic diet — is that product available and appropriate for my child's age and nutritional needs, and would you recommend it as part of their treatment regardless of whether we join this study?
4Given that the recruitment status for this trial is currently unknown, is it still actively enrolling patients, and if not, are there other ways my child could access the ketogenic diet as a treatment for their drug-resistant epilepsy?
5Before considering this study, I'd like to understand — at what point does the ketogenic diet become a recommended option for a child with drug-resistant epilepsy, and are there other medications or treatments we should try first?
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.