Drug-Resistant Epilepsy
Conditions
Interventions
Treatment Group:Monoclonal Antibody (SIF001)
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
14 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1: Diagnosed with drug-resistant epilepsy; 2: Age = 14 years and = 50 years, with no gender restrictions; 3: The subject is deemed unlikely to benefit from resective surgery based on pre-surgical evaluation for epilepsy, or the subject refuses such surgery; 4: The subject is unsuitable for or refuses implantable treatments such as vagus nerve stimulation or deep brain stimulation; 5: Epileptic seizures occur = 1 time per day, including focal and/or generalized seizures; 6: Has not participated in other clinical trials within the past three months; 7: The subject and their family have reasonable expectations that the subject can independently or with family assistance record a seizure diary; 8: Willing to participate in the trial and has signed the written informed consent; 9: No contraindications to monoclonal antibody therapy; 10: Body weight = 50 kg, with a body mass index (BMI) between 18 and 35.
Exclusion criteria
Exclusion criteria: 1: Pregnant women, women planning to become pregnant within the next year, or breastfeeding women; 2: Clinically significant or unstable medical conditions (including alcohol and/or substance abuse) or progressive central nervous system diseases; 3: Severe physical illnesses involving the heart, lungs, liver, kidneys, etc.; 4: Subjects with poor compliance, or who are deemed unsuitable for participation in the clinical trial by the investigator; 5: History of psychiatric disorders within the past 6 months (such as major depression, schizophrenia, or bipolar disorder); 6: Subjects deemed unsuitable for resective surgery, implantable vagus nerve stimulation, deep brain stimulation, or ketogenic diet by multidisciplinary consultation, or who refuse these treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rate of seizure frequency at Day 28 post-treatment compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction rate of seizure frequency compared to baseline after treatment.;Number of epileptiform discharges per hour recorded on EEG.;Change in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) scores relative to baseline after treatment.;Change in the Hamilton Depression Rating Scale (HAM-D) scores relative to baseline after treatment.;Change in the Hamilton Anxiety Rating Scale (HAM-A) scores relative to baseline after treatment.; | — |
Countries
China
Contacts
Public ContactYuping Wang
Xuanwu Hospital, Capital Medical University
Outcome results
None listed