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

Study Overview
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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.

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.

Official Title
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An Open Label Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center

Conditions
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Cluster Seizure

Intervention / Treatment
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* Drug: Midazolam oral solution
* Drug: ClonazePAM Oral Product
* Other: Usual medication/ traditional


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open label, randomnized, prospective clinical trial, with a 1:1:1 aleatorization of a single third level specialized neurological center.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orodispersable clonazepam<br>50 patients will receive oral orodispersable clonazepam. | Drug: ClonazePAM Oral Product<br>* Orodispersable<br>* Other names: clonazepam;|
| Experimental: Buccal midazolam<br>50 patients will receive buccal midazolam. | Drug: Midazolam oral solution<br>* Buccal administration<br>* Other names: midazolam;|
| Active Comparator: Conventional treatment<br>50 patients will receive usual/ conventional treatment of seizure clusters | Other: Usual medication/ traditional<br>* Medication that is usually used in the emergency department<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline seizure frequency comparison using buccal midazolam, orodispersable clonazepam versus usual care efficacy for seizure clusters | Seizure frequency description, using the Engel Score of Seizure Outcomes | 1,3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline seizure recurrence in 6 months | Seizure frequency description, using the Engel Score of Seizure outcomes. | 6 months | 
| Change from baseline quality of life assessed by the QOLIE-31 from baseline | Quality of life questionnaire: QOLIE-31 (Quality Of Life in Epilepsy version 31) is a standarized epilepsy quality of life measuring tool compared to initial score at recruitment. QOLIE-31 consists of 31 items distributed in 7 areas: preoccupation for seizures, general quality of life, emotional well-being, energy/fatigue, cognitive alterations, medication effects, and social functioning. Final evaluation of the points is ranging from 10 points (worse quality of life) and 50 points (best quality of life). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seizure cluster, epilepsy, rescue medication, benzodiazepines