RecruitingNot ApplicableNCT06056349

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


Sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Enrollment

150 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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.

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Interventions

DRUGMidazolam oral solution

Buccal administration

DRUGClonazePAM Oral Product

Orodispersable

OTHERUsual medication/ traditional

Medication that is usually used in the emergency department


Locations(1)

Instituto Nacional de Neurología y Neurocirugía "Dr. Manuel Velasco Suárez"

Mexico City, Mexico City, Mexico

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NCT06056349