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:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT05958069
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 8 years old;
2. It meets the NORSE diagnostic criteria: (1) newly emerging intractable status epilepticus, (2) no previous epilepsy or other related nervous system disease, (3) no clear acute structural, toxic and metabolic factors leading to intractable status epilepticus;
3. NORSE medical history ≥ 6 months, with a frequency of ≥ 4 episodes per month;
4. Take two or more antiepileptic drugs;
5. The patient and their family members are aware of this study and sign an informed consent form.
Exclusion Criteria:
1. Patients who are allergic to any component of tetracycline or product formulation;
2. Persistent state of epilepsy;
3. Adjustment of antiepileptic drugs during the trial period;
4. Immunotherapy, ketogenic diet and other added treatments were not stable or other treatments were started during the trial;
5. Epilepsy surgery;
6. In the treatment of vagus nerve stimulation and transcranial magnetic stimulation;
7. Patients with severe infection, cerebrovascular disease, malignant tumor and other nervous system disease, and patients with severe dysfunction of heart, liver, kidney and other organs;
8. Non epileptic seizures such as syncope and hysteria;
9. Participating in clinical trials of other drugs;
10. Women during lactation or pregnancy;
11. Incomplete clinical data;
12. The patient or family member withdraws the informed consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT05958069
Study Brief:
Protocol Section:
NCT05958069