Epilepsy
Conditions
Interventions
Observation group (Treatment with Diazepam Nasal Spray as indicated by a history of frequent seizures):None
Sponsors
Fudan University Affiliated Pediatric Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Epilepsy is clinically diagnosed, and frequent seizures still occur during stable antiepileptic drug regimen (stable medication for at least 2 months), at least 6 seizures within 1 year before enrollment, and at least 1 seizure in the first 2 months; Patients who, in the opinion of the investigator, required diazepam nasal spray for seizure control; 2. children aged two years and -18 years; Consent to participate in the study, ability to cooperate with follow-up, and signing of informed consent.
Exclusion criteria
Exclusion criteria: 1. Have severe (but not limited to) infection, poisoning, nutrition and metabolism disorder, endocrine disease, five-organ disease, skin, respiratory and circulating system disease, digestive system disease, urinary system disease, hematological system disease, rheumatism immunization disease or neuropsychiatric disease, etc., and the investigator considers that the subject has potential safety hazard or the disease itself or/and relevant treatment will interfere with the trial; 2. History of allergy or suspected allergy to diazepam or other benzodiazepines and excipients of the investigational product; 3. He has a history of drug abuse, mental illness or alcoholism and cannot cooperate with the clinical investigator; 4. Acute angle closure glaucoma; Other patients who, in the opinion of the investigator, were not eligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event data within 28 days after administration of Diazepam Nasal Spray, including adverse events (AEs): Type, incidence, severity, relationship to trial drug, etc.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of secondary administration of diazepam nasal spray within 12 hours and 24 hours after the subjects had frequent seizures;;Rate of subjects with seizure discontinuation within 5 and 10 minutes after administration of Diazepam Nasal Spray; | — |
Countries
China
Contacts
Public ContactWangyi
Fudan University Affiliated Pediatric Hospital
Outcome results
None listed