Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT05886205
Eligibility Criteria:
Inclusion Criteria:
1. Before conducting this study, understand and sign the informed consent form and comply with the requirements of this study;
2. The subjects are patients with focal epilepsy aged 18 to 70 years (inclusive), regardless of gender;
3. The subjects must comply with the definition of drug resistant epilepsy (ILAE);
4. Subjects must take 1-6 types of anti-epileptic drugs (AEDs), and before entering the screening period, they must take unadjusted types and stable doses of AEDs for at least 4 weeks;
5. Throughout the entire research process, the subject/legal guardian must be able to accurately record the log of epileptic seizures;
6. Subjects must experience at least 4 countable seizures within 28 days prior to the screening period;
7. The subjects are willing and able to comply with the research requirements.
Exclusion Criteria:
1. Unwilling or unable to follow the procedures stipulated in the agreement;
2. Pregnant or lactating women, or women with reproductive potential who are unable or unwilling to take appropriate contraceptive measures;
3. Other uncontrollable diseases that may interfere with the research results, including but not limited to infection, hypertension, diabetes, cardiovascular and cerebrovascular diseases, etc;
4. There are situations that may increase the risk of participating in experiments or research product use, such as liver enzyme elevation exceeding twice the normal upper limit and/or GFR\<60 mL/min/1.73 m2;
5. Have a history of drug abuse, alcohol dependence, or smoking within one month;
6. Patients with status epilepticus within one month;
7. Have potential progressive nervous system disease, such as encephalitis, brain tumor, multiple sclerosis or dementia;
8. Patients who plan to undergo epilepsy surgery within six months;
9. Patients with abnormal or diseased nasal structures;
10. Patients with cerebrospinal fluid rhinorrhea;
11. Patients whose family members have not been able to proficiently and correctly master the nasal drip method through standardized training
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05886205
Study Brief:
Protocol Section:
NCT05886205