NCT06056349

Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center

An Open Label Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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) of seizure clusters in a third level center of care in Mexico city.

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 of the use of buccal midazolam as a treatment of seizure clusters in comparison with orodispersable clonazepam vs usual care. Secondary objective: To identify patients that present seizure clusters and risk factors associated with the diagnosis. To evaluate the quality of life after drug administration, to evaluate the adverse events associated with the medications. To establish seizure recurrence and mortality in 6 months' follow up.

Conditions

• Cluster Seizure

Interventions

Type	Name	Description
DRUG	Midazolam oral solution	Buccal administration
DRUG	ClonazePAM Oral Product	Orodispersable
OTHER	Usual medication/ traditional	Medication that is usually used in the emergency department

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-09-28
• Last updated: 2024-05-31

Locations

1 site across 1 country: Mexico