A double blinded study of oral MCT oil vs. high-oleic sunflower oil as an add-on treatment to adult participants with medically refractory epilepsy

Samsung Medical Center0 个研究点目标入组 100 人开始时间: 待定最近更新: 2023年1月10日

适应症

试验速览

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•(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

•(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)

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