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

Drug Resistant Epilepsy Clinical Trial

— KEOPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075485
• Other study ID #: 2023-A01073-42
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: Nutricia Nutrition Clinique
• Contact: Elmire DEGOUL-COMBESCOT, PhD
• Phone: +33 (0) 6 27 91 97 08
• Email: Elmire.DEGOUL[@]danone.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

NUTRICIA has developed the KetoCal® range (4:1 and 3:1), a food for special medical purposes (DADFMS), to help healthcare professionals and patients establish and maintain a CR. KetoCal® 4:1 features a 4:1 ratio of fat to (carbohydrate + protein), while containing vitamins, minerals, trace elements and fiber. Similarly, KetoCal® 3:1 has a 3:1 ratio of lipids / (carbohydrates + proteins), while containing vitamins, minerals, trace elements and fiber. The KetoCal® range can be consumed orally, as a drink after dilution in hot water, incorporated as an ingredient in a recipe or administered by enteral feeding tube. The KEOPS study is designed to gather real-life data on the therapeutic value of using the KetoCal® range in the management of drug-resistant epilepsy in infants (from 5 months) and children up to 18 years of age. Patients will be managed according to standard care practices. Initiation of ketogenic dieting will be at the investigator's discretion during the child's hospitalization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 133
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Ketogenic Dieting

Intervention

Other:
• Ketocal
ketogene diet

Locations

Country	Name	City	State
France	CHRU Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Nutricia Nutrition Clinique	Euraxi Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of compliance	Retention rate which is defined as the proportion of patients who have continued KD for up to 6 months.	6 months
Secondary	Duration of compliance	Describe the duration of KD compliance.	From Month 1 to Month 6
Secondary	Efficacy of KD	Describe the efficacy of KD. Efficacy is defined as responders to KD with seizure frequency reduced by more than 50%, or no seizure frequency in the case of total response to CR in the last week.	From Month 1 to Month 6
Secondary	KD tolerance.	Describe KD tolerance as a number of AE reported	From inclusion to Month 6
Secondary	QoL evolution	Describe changes in patients' quality of life following initiation of KD at inclusion, and M6; using PedsQL ™ questionnaires	From inclusion to Month 6
Secondary	Influence of KD	Total number of antiepileptic drugs used for each child including their current treatment until the end of the study.	From inclusion to Month 6
Secondary	Ketosis achievement	Evaluate the time it takes to achieve ketosis. Ketosis will be assessed by ketonuria or ketonemia, depending on the habits of each center.	From inclusion to Month 6