Status:
RECRUITING
Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center
Lead Sponsor:
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Conditions:
Cluster Seizure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to determine the efficacy in seizure reduction when comparing orodispersable clonazepam versus usual treatment (i.e. medication load, intravenous high- dose benzodiazepines) o...
Detailed Description
This is an open label, randomized, prospective clinical trial, with a 1:1:1 aleatorization of a single third level specialized neurological center. Primary objective: To evaluate the clinical impact ...
Eligibility Criteria
Inclusion
- At least age of 18
- Patient available for follow-up
- Previous diagnosis of epilepsy
- Patient meets criteria for seizure clusters (3 or more seizures in a period of 24 hours)
Exclusion
- Risk factors for epilepsy have been identified and uncontrolled.
- Younger than 18 years olf
- Follow- up in another healthcare unit
- No previous epilepsy diagnosis
- Adequate control of epilepsy
- Patient meets criteria for clinical or electrographic status epilepticus.
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06056349
Start Date
May 1 2023
End Date
December 31 2024
Last Update
May 31 2024
Active Locations (1)
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1
Instituto Nacional de Neurología y Neurocirugía "Dr. Manuel Velasco Suárez"
Mexico City, Mexico City, Mexico, 14269