Intranasal Diazepam Spray for Termination of Generalized Convulsive Status Epilepticus: a single arm Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500101766

Enrollment

Unknown

Registered

2025-04-29

Start date

2025-05-01

Completion date

Unknown

Last updated

2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epilepsy

Interventions

Treatment Group:Intranasal Diazepam Spray

Eligibility

Sex/Gender

All

Age

14 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=14 years old; 2. Patients with generalized convulsive status epilepticus (GCSE) (including generalized convulsive status epilepticus secondary to focal epilepsy, generalized convulsive status epilepticus and unknown origin): generalized tonic-clonic seizures for more than 5 minutes (reliable medical history) or 2 or more generalized tonic-clonic seizures, during which consciousness does not return to normal, and the total duration of the seizure is less than 30 minutes; 3. No anti-seizure drug treatment has been given after the onset of the disease; 4. Obtain written or oral informed consent from the patient's guardian.

Exclusion criteria

Exclusion criteria: 1. Epileptiform seizures caused by acute severe trauma, hypoglycemia, hyponatremia, cardiac arrest, etc.; 2. Previous COPD or acute pulmonary infection; 3. Heart rate is less than 40 beats/min; 4. History of previous second- or third-degree atrioventricular block; 5. Acute narrow-angle glaucoma; 6. Known allergy to benzodiazepines; 7. Pregnant and lactating females; 8. Any other conditions that the investigator considers unsuitable to participate in the study.

Design outcomes

Primary

Measure	Time frame
Proportion of seizures terminated within 10 minutes of medication.;	—

Secondary

Measure	Time frame
The proportion of patients requiring remedial treatment;The time from medication to the end of epileptic seizure;The proportion of patients with respiratory depression within 30 minutes;The proportion of patients intubated within 30 minutes;The proportion of patients who have another acute epileptic seizure within 12 hours;The proportion of patients who do not need to use anti-epileptic drugs within 12 hours;	—

Measure

Time frame

The proportion of patients requiring remedial treatment;The time from medication to the end of epileptic seizure;The proportion of patients with respiratory depression within 30 minutes;The proportion of patients intubated within 30 minutes;The proportion of patients who have another acute epileptic seizure within 12 hours;The proportion of patients who do not need to use anti-epileptic drugs within 12 hours;

—

Countries

China

Contacts

Public ContactWang Xin

Zhongshan Hospital, Fudan University

wang.xin@zs-hospital.sh.cn+86 21 6404 1990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026