focal epilepsy
Conditions
Interventions
Low dose group:Injection administration
High dose group: Injection administration
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years old, regardless of gender. 2. The diagnosis of the subject's electroencephalogram (EEG), brain CT scanning image, or brain MRI inspection result conforms to the criteria for focal focal epilepsy of International League against Epilepsy. 3. Having the epileptic history of 4 or more per month within 1 month before screening period. 4. Taking 1-2 fixed dose anti-epileptic drugs (such as levetiracetam, valproic acid, etc.) within one month before screening period, without adjusting the drug type and dose during the clinical trial. 5. Subjects for ketogenic diet therapy and having started this therapy for 5 weeks before enrollment. 6. Understand and willingness to participate in this clinical trial and providing signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. The epileptic history having seizures lasting for more than 30 minutes or consciousness without returning to baseline level before 12 months . 2. Patients with any diseases who may require treatment or may be impossible for completing the entire clinical trial (excluding epilepsy). 3. Patients with central nervous system infection, demyelinating diseases, neurodegenerative diseases, cerebrovascular diseases, intracranial malignant tumor with survival period of less than 3 months, etc; 4. Subjects who currently have acute gastrointestinal symptoms (such as nausea, vomiting, diarrhea, and heartburn) (when signing the informed consent form). 5. Patients with active digestive diseases. 6. Subjects who are positive for hepatitis B surface antigen (HBsAg), human immunodeficiency virus antibody (anti HIV), hepatitis C antibody (anti HCV), and Treponema pallidum antibody. 7. Patients with any personal or family history of cardiac conduction abnormalities; with any family history of QT prolongation syndrome; if the 12-lead electrocardiogram result of patients show QTc>450 msec during screening, repeating the test twice, the average value of QTc still exceeds 450 msec thrice. 8. The subject results of vital signs, physical examinations, and laboratory tests are abnormal with clinical significance being determined by the researcher; (platelet count 400ml) or blood donation/blood components within 3 months before participating in this clinical trial, or planning to donate blood/blood components during this clinical trial. 11. Patients with the history of alcohol abuse, or those who are habitual drinking for more than 2 measurement units per day within the two years prior to this clinical trial (1 measurement unit is equivalent to 357 mL beer (5% alcohol content), 44 mL spirits (44% alcohol content), or 147 mL wine (12% alcohol content). 12. Intermittent first aid using benzodiazepines within 30 days before baseline (1-2 times within 24 hours can be considered as one first aid) more than twice; 13. Subjects having lifetime history of suicide attempts (including actual attempts, interrupted attempts, or abandoned attempts), or having suicidal ideation within the past 6 months, as indicated by a positive answer ("Yes") to question 4 or question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) during the screening period. 14. patients with severe cognitive impairment without family care. 15. Pregnant or lactating women, or subjects (or their partners) planning to have pregnancy plan during this clinical trial and within 3 months after the end of this clinical trial; or refusing to take non-drug contraceptive measures during this clinical trial and within 3 months after the end of this clinical trial. 16. Patients with the history of drug abuse. 17. Allergic constitution, or known allergy to isopropyl bisphenol or its emulsifier components. 18. Subjects to be unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| security and tolerance indexes;pharmacokinetic indexes;effectiveness exploration indexes; | — |
Countries
China
Contacts
Public ContactWu Xintong
West China Hospital of Sichuan University
Outcome results
None listed