Focal Epilepsy in the Motor Cortex
Conditions
Interventions
Treatment group:GA002 intracranial injection
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 14-50, if under 18, the subject must agree to comply with all protocol requirements and ensure that the subject and their parents or legal guardians are willing to provide consent on the Informed Consent Form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Human Research Ethics Committee (HREC) before participating in any study-related procedures. 2. Patients with focal epilepsy in the motor cortex, seizure frequency: =2 seizures per week on average in the past 3 months, with an interval of <28 days between any two seizures. 3. Have received standardized treatment with two or more antiepileptic drugs for 2 years or more, but still unable to effectively control seizures. 4. As judged by the investigator, the patient has shown no significant change in disease status on the same antiepileptic drug regimen for the past 3 months. 5. Have been stably taking the current antiepileptic drugs for at least 3 months at baseline and are expected not to change the current medication type and dosage before the end of the effectiveness observation period in this trial. 6. The patient voluntarily agrees to participate in the trial and sign the informed consent form under full understanding, with the ability to receive and make phone calls; at the time of signing the informed consent, the research participant must have a caregiver who is =18 years old; the caregiver must be a relative, partner, legally authorized representative of the research participant, or someone who provides daily care for the research participant and has a significant personal relationship with them; the caregiver must be able to identify and observe the research participant's seizures. 7. Stereoelectroencephalography (SEEG) is required to identify the epileptogenic rhythms in the central or motor areas. 8. Laboratory test values of the subject meet the criteria. 9. Male or female subjects of childbearing potential agree to use effective contraception from the time of signing the informed consent form until at least 6 months after discontinuing the use of clozapine (oral contraceptives are prohibited). 10. According to the investigator's judgment, the subject is deemed reliable and able to comply with the trial protocol , visit schedule, and medication. 11. No significant underlying diseases or cardiopulmonary functional impairments.
Exclusion criteria
Exclusion criteria: 1.Patients with malignant central nervous system tumors or degenerative diseases. 2. Patients with significant fluctuations in seizure intervals or long seizure cycles as determined by the investigator. 3.Patients with secondary epilepsy due to intracranial malignant tumors, neurodegenerative diseases, head trauma, cerebral hemorrhage or infarction, infectious diseases, cerebrovascular diseases, or other organic lesions. 4. Patients with severe psychiatric disorders. 5. Patients who refuse to participate in this study after being informed or have contraindications to treatment and surgery as determined by the investigator. 6. Patients who are unable or unsuitable to complete the required non-invasive or invasive assessments. 7. Patients with a history of previous intracranial surgery (except for patients who underwent minimally invasive puncture or radiofrequency or laser ablation for diagnostic purposes, or patients with vagus nerve stimulators or deep brain stimulators implanted). 8. Patients with a history of contraindications to the study drugs during the trial period (such as chlorpromazine or other components of chlorpromazine, anesthetics, contrast agents, mannitol, antibiotics, etc.). 9. Patients who have received any gene therapy. 10. Participants who have participated in any other drug clinical trials within 3 months prior to the signing of the informed consent form, except for non-interventional clinical trials; participants who have participated in device clinical trials may be assessed by the investigator for inclusion. 11. Patients with severe liver or kidney diseases, hypotension, or glaucoma. 12. Patients with bone marrow failure disorders. 13. Patients who have previously taken or are currently taking drugs that cause granulocytopenia or bone marrow suppression. 14. Patients who have previously taken clozapine and developed either agranulocytosis or severe neutropenia.. 15. Patients who are positive for hepatitis B surface antigen and/or hepatitis B e antigen, positive for hepatitis C virus antibodies, positive for human immunodeficiency virus antibodies, or positive for syphilis spirochete antibodies during the baseline period. 16. Patients with severe heart diseases, including myocardial diseases, heart failure, arrhythmias, ischemic heart disease, and congenital heart diseases. 17. Patients who are severely obese, with a BMI =30kg/m2. 18. Patients with digestive system diseases or digestive system surgeriesthat may affect drug absorption, metabolism, or excretion, or patients with any complex systemic diseases that may affect central nervous system function, such as malignant tumors. 19. Patients with a history of alcohol/drug abuse in the past 2 years. 20. Pregnant or breastfeeding women. 21. Patients for whom the investigator deems there are other circumstances that may interfere with the evaluation of effectiveness and safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerance of GA002; | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy of GA002;The PK and immunogenicity of GA002; | — |
Countries
China
Contacts
Public ContactZhao Guoguang
Department of Neurosurgery of Xuanwu Hospital Capital Medical University
Outcome results
None listed