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

NCT06075485 | Recruiting

• 1 other identifier: 2023-A01073-42
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Resistant Epilepsy; Ketogenic Dieting

Keywords

ketogenic diet; epilepsy; drug resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of compliance

  From Month 1 to Month 6

• Efficacy of KD

  From Month 1 to Month 6

• KD tolerance.

  From inclusion to Month 6

• QoL evolution

  From inclusion to Month 6

• Influence of KD

  From inclusion to Month 6

Study Arms (1)

Patient

Infants (from 5 months) and children up to 17 years of age follow up for drug resistant epilepsy

Other: Ketocal

Interventions

Ketocal OTHER

ketogene diet

Patient

Eligibility Criteria

• Age: 5 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A total of 133 eligible patients will be recruited in this project. The target population of our project will be infants (from 5 months of age) and children up to 18 years of age treated for drug-resistant epilepsy, who, depending on the physician in charge of the patient, may benefit from the initiation of a KetoCal® 3:1 or 4:1 CR, depending on the child's age. We exclude from our study protected legal representatives of minors (under guardianship, curatorship, minor parents). In addition, people taking part in this study will not be able to take part in any other interventional or observational research for the duration of the study. A 6-month exclusion period is planned as part of this project.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutricia Nutrition Clinique: lead
• Euraxi Pharma: collaborator

Study Sites (1)

CHRU Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Elmire DEGOUL-COMBESCOT, PhD

CONTACT

+33 (0) 6 27 91 97 08; Elmire.DEGOUL@danone.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 10, 2023
• Study Start: January 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)