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

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Status: Enrolling

Conditions: Cluster Seizure

Treatments: Drug: Midazolam oral solution; Other: Usual medication/ traditional; Drug: ClonazePAM Oral Product

Study type: Interventional

Funder types: Other

Identifiers

NCT06056349

05/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Orodispersable clonazepam

Experimental group

Description:

50 patients will receive oral orodispersable clonazepam.

Treatment:

Drug: ClonazePAM Oral Product

Buccal midazolam

Experimental group

Description:

50 patients will receive buccal midazolam.

Treatment:

Drug: Midazolam oral solution

Conventional treatment

Active Comparator group

Description:

50 patients will receive "usual/ conventional treatment of seizure clusters"

Treatment:

Other: Usual medication/ traditional