Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center
150 patients around the world
Available in Mexico
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.
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
1Research sites
150Patients around the world
This study is for people with
Epilepsies
Epilepsy
Requirements for the patient
From 18 Years
All Gender
Medical requirements
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)
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.
Sites
Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Recruiting
Av. Insurgentes Sur 3877, La Fama, Tlalpan, 14269 Ciudad de México, CDMX
SponsorEl Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez