Drug Resistant EpilepsyKEOPSNCT06075485
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
An observational study of Drug Resistant Epilepsy and Ketogenic Dieting, run by Nutricia Nutrition Clinique at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 5 months to 18 years
- Conditions the study is for
- Drug Resistant Epilepsy, Ketogenic Dieting
- What is being tested?
- Ketocal
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2024to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Lille
Lille, 59037
Adeline TRAUFFLER, MD
About this study
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.
Read the detailed 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.
- Conditions
- Drug Resistant Epilepsy, Ketogenic Dieting
- Being tested
- Ketocal
- Keywords
- ketogenic diet, epilepsy, drug resistance
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetocalOther
ketogene diet
| Study group | Role | What they receive |
|---|---|---|
| Patient | Infants (from 5 months) and children up to 17 years of age follow up for drug resistant epilepsy Receives: Other: Ketocal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of compliance
Retention rate which is defined as the proportion of patients who have continued KD for up to 6 months.
Measured: 6 months
Secondary outcomes (6)
Duration of compliance
Describe the duration of KD compliance.
Measured: From Month 1 to Month 6
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.
Measured: From Month 1 to Month 6
KD tolerance.
Describe KD tolerance as a number of AE reported
Measured: From inclusion to Month 6
QoL evolution
Describe changes in patients' quality of life following initiation of KD at inclusion, and M6; using PedsQL ™ questionnaires
Measured: From inclusion to Month 6
Influence of KD
Total number of antiepileptic drugs used for each child including their current treatment until the end of the study.
Measured: From inclusion to Month 6
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.
Measured: From inclusion to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start15 Jan 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Nutrition Clinique
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075485
- Sponsor's protocol ID
- 2023-A01073-42
- Acronym
- KEOPS
- Status last verified
- Jan 2024
- First submitted
- 21 Sep 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06075485
- Acronym / sponsor ID
- KEOPS / 2023-A01073-42
- Conditions
- Drug Resistant Epilepsy, Ketogenic Dieting
- Keywords
- ketogenic diet, epilepsy, drug resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Nutricia Nutrition CliniqueIndustry (pharma, biotech, devices)
- Collaborators
- Euraxi Pharma
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: KetocalInfants (from 5 months) and children up to 17 years of age follow up for drug resistant epilepsy |
Who may qualify
- Ages
- 5 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketocalketogene diet | Other | Patient |
Primary outcome
Description of compliance
Time frame: 6 months
Retention rate which is defined as the proportion of patients who have continued KD for up to 6 months.
6 secondary outcomes
Duration of compliance
Time frame: From Month 1 to Month 6
Efficacy of KD
Time frame: From Month 1 to Month 6
KD tolerance.
Time frame: From inclusion to Month 6
QoL evolution
Time frame: From inclusion to Month 6
Influence of KD
Time frame: From inclusion to Month 6
Ketosis achievement
Time frame: From inclusion to Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Resistant Epilepsy and Ketogenic Dieting, run by Nutricia Nutrition Clinique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elmire DEGOUL-COMBESCOT, PhD (+33 (0) 6 27 91 97 08, Elmire.DEGOUL@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of compliance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.