Overview
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 highdose benzodiazepines) of seizure clusters in a third level center of care in Mexico city.
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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.