epilepsy
Conditions
Interventions
Group of epilepsy:NA
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Clinically diagnosed epilepsy, while on a stable antiepileptic medication regimen (stable medications for at least 2 months) still have frequent seizures with at least 6 seizures within 1 year prior to enrollment, and had at least 1 seizurein the first 2 months; in the opinion of the investigator requires diazepam nasal spray for seizure control for patients with seizures; 2. Age >= 6 years; 3. Agree to participate in this study, be able to cooperate with the follow-up, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding females or those who have a pregnancy plan within 6 months; 2. Suffering from serious (not limited to) infection, poisoning, nutritional and metabolic disorders, endocrine diseases, facial diseases, skin, respiratory and circulatory system diseases, digestive system diseases, urinary system diseases, blood system diseases, rheumatic immune diseases or neuropsychiatric diseases, etc., and the investigator believes that the subject has potential safety hazards or the disease itself or/and related treatments will interfere with the conduct and evaluation of the trial; 3. History of allergy or suspected allergy to diazepam or other benzodiazepines and test drug excipients; 4. Those who have a history of drug abuse, mental illness or alcoholism, and cannot cooperate with clinical research; 5. Patients with acute angle-closure glaucoma; 6. Other patients who, in the opinion of the investigator, are not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events within 28 days after administration of diazepam nasal spray; | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of second doses within 12 hours and 24 hours after administration of diazepam nasal spray;;Percentage of subjects with seizure termination within 5 minutes and 10 minutes after diazepam nasal spray; | — |
Countries
China
Contacts
Public ContactQun Wang
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed