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

Sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez (Other)

Overall Status

Recruiting

CT.gov ID

NCT06056349

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

18.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cluster Seizure	Drug: Midazolam oral solution Drug: ClonazePAM Oral Product Other: Usual medication/ traditional	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Orodispersable clonazepam 50 patients will receive oral orodispersable clonazepam.	Drug: ClonazePAM Oral Product Orodispersable Other Names: clonazepam
Experimental: Buccal midazolam 50 patients will receive buccal midazolam.	Drug: Midazolam oral solution Buccal administration Other Names: midazolam
Active Comparator: Conventional treatment 50 patients will receive "usual/ conventional treatment of seizure clusters"	Other: Usual medication/ traditional Medication that is usually used in the emergency department

Arm

Intervention/Treatment

Experimental: Orodispersable clonazepam

50 patients will receive oral orodispersable clonazepam.

Drug: ClonazePAM Oral Product

Orodispersable

Other Names:

clonazepam

Experimental: Buccal midazolam

50 patients will receive buccal midazolam.

Drug: Midazolam oral solution

Buccal administration

Other Names:

midazolam

Active Comparator: Conventional treatment

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

Other: Usual medication/ traditional

Medication that is usually used in the emergency department

Outcome Measures

Primary Outcome Measures

Change from baseline seizure frequency comparison using buccal midazolam, orodispersable clonazepam versus usual care efficacy for seizure clusters [1,3 and 6 months]
Seizure frequency description, using the Engel Score of Seizure Outcomes

Secondary Outcome Measures

Change from baseline seizure recurrence in 6 months [6 months]
Seizure frequency description, using the Engel Score of Seizure outcomes.
Change from baseline quality of life assessed by the QOLIE-31 from baseline [6 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)