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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Cluster Seizure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

This is an open label, randomnized, prospective clinical trial, with a 1:1:1 aleatorization of a single third level specialized neurological center.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Orodispersable clonazepam

50 patients will receive oral orodispersable clonazepam.

Group Type EXPERIMENTAL

ClonazePAM Oral Product

Intervention Type DRUG

Orodispersable

Buccal midazolam

50 patients will receive buccal midazolam.

Group Type EXPERIMENTAL

Midazolam oral solution

Intervention Type DRUG

Buccal administration

Conventional treatment

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

Group Type ACTIVE_COMPARATOR

Usual medication/ traditional

Intervention Type OTHER

Medication that is usually used in the emergency department

Interventions

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Midazolam oral solution

Buccal administration

Intervention Type DRUG

ClonazePAM Oral Product

Orodispersable

Intervention Type DRUG

Usual medication/ traditional

Medication that is usually used in the emergency department

Intervention Type OTHER

Other Intervention Names

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midazolam clonazepam

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No