None listed
Conditions
Interventions
Dietary Supplement : MCT oil intake therapy (intervention test) and sunflower oil intake therapy (control test), which subjects received as part of the clinical trial, were evaluated to evaluate the e
3 weeks)
- Period to determine the effective or maximum tolerated dose for reducing seizure frequency in the intervention oil intake group (MCT oil) (titration was also conducted in the control oil in
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Adult epileptic patients between the ages of 18 and 70 (2) Patients who experienced at least 2 seizures of an eligible type (*) per month during the 2 months prior to enrollment in this clinical trial despite treatment with at least one antiepileptic drug at a clinically appropriate dose (3) If there is no change in the history of taking antiepileptic drugs for 4 weeks prior to enrollment (4) A person who consented to participate in the clinical trial (if voluntary consent is difficult, there must be a proxy (parent or guardian) who can consent to participate in the clinical trial on behalf of the subject) (5) Women of childbearing potential must have a negative serum ßhCG result at the first visit and a negative urine pregnancy test prior to randomization at the second visit. Female subjects of childbearing potential must abstain from abstinence or agree to use at least one method of contraception. If the subject is using a hormonal type of birth control, they must agree to use an additional approved second method of contraception. - The method of contraception specified in this study is the use of “condoms”. (*Eligible seizure types: complex partial seizures, secondary generalized seizures, simple partial seizures with motor symptoms, primary generalized seizures, spasticity tonic-clonic seizures, atonic seizures
Exclusion criteria
Exclusion criteria: (1) If you have a severe intellectual disability (2) If you have a history of major mental illness (e.g. mental illness or psychosis requiring hospitalization) (3) If there is a history of substance abuse, eating disorder, or irritable bowel syndrome or disorder (4) If you have had psychogenic non-epileptic seizures (5) Patients with seizure clusters or other reasons that make the count of seizures inaccurate (6) Women who are pregnant or breastfeeding (7) In the case of disorders affecting the oxidation of medium-chain (KB1) and short-chain fatty acids (8) Patients receiving a ketogenic diet or other calorie-controlled diets that may interfere with the implementation of the protocol of this clinical trial (if the patient agrees to discontinue the diet before and during the trial, it can be included as a subject. Baseline A withdrawal period of at least one month is required before the visit)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure reduction rates in MCT oil intake group compared to sunflower oil intake group | — |
Secondary
| Measure | Time frame |
|---|---|
| Drop-out rate in the MCT group, number of fatal adverse events in the MCT group | — |
Countries
Korea, Republic of
Contacts
Public ContactJeongsik Kim
Samsung Medical Center
Outcome results
None listed