Drug Resistant Epilepsy Clinical Trial
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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04378075 -
A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy
|
Phase 2/Phase 3 | |
Recruiting |
NCT05928598 -
Goals for Epilepsy Clinic Visits Trial
|
N/A | |
Recruiting |
NCT05539287 -
Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy
|
Phase 2 | |
Not yet recruiting |
NCT04601974 -
Lentiviral Gene Therapy for Epilepsy
|
Phase 1/Phase 2 | |
Completed |
NCT02982824 -
Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy
|
N/A | |
Recruiting |
NCT05485558 -
the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy
|
Phase 2 | |
Not yet recruiting |
NCT04553354 -
Cortical Resections in Drug Resistant Epilepsy
|
||
Recruiting |
NCT04999046 -
NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
|
N/A | |
Recruiting |
NCT04714996 -
Efficacy, Safety and Pharmacokinetics of ES-481 in Adult Patients With Drug Resistant Epilepsy
|
Phase 2 | |
Recruiting |
NCT04839601 -
RNS System RESPONSE Study
|
N/A | |
Recruiting |
NCT06059157 -
Epileptogenic Network Visualisation With Advanced MRI
|
N/A | |
Recruiting |
NCT05947656 -
Evaluation of the NaviFUS System in Drug Resistant Epilepsy
|
N/A | |
Recruiting |
NCT05393518 -
Electroclinical Correlation of Anxiety
|
N/A | |
Not yet recruiting |
NCT05555537 -
MiRNA223 and HMGB1 as Apredictos for Drug Resistant Epilepsy
|
||
Completed |
NCT03419000 -
Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY
|
N/A | |
Enrolling by invitation |
NCT06341075 -
Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Drug-resistant Epilepsy
|
N/A | |
Not yet recruiting |
NCT05527093 -
Cartography of Social Cognition Network and Their Alterations in Patients With Epilepsy
|
N/A | |
Recruiting |
NCT05697614 -
The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children
|
Phase 4 | |
Recruiting |
NCT06309251 -
Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
|
||
Recruiting |
NCT06432907 -
StereoEEG Motor Neuronal Potentials Decoding
|
N/A |