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

Primary Purpose

Cluster Seizure

Status

Recruiting

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Midazolam oral solution

ClonazePAM Oral Product

Usual medication/ traditional

About this trial

This is an interventional treatment trial for Cluster Seizure focused on measuring seizure cluster, epilepsy, rescue medication, benzodiazepines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Instituto Nacional de Neurología y Neurocirugía "Dr. Manuel Velasco Suárez"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Orodispersable clonazepam

Buccal midazolam

Conventional treatment

Arm Description

50 patients will receive oral orodispersable clonazepam.

50 patients will receive buccal midazolam.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline seizure recurrence in 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

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).

Full Information

NCT ID

NCT06056349

First Posted

April 25, 2023

Last Updated

September 26, 2023

Sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

1. Study Identification

Unique Protocol Identification Number

NCT06056349

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2023 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cluster Seizure

Keywords

seizure cluster, epilepsy, rescue medication, benzodiazepines

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Orodispersable clonazepam

Arm Type

Experimental

Arm Description

50 patients will receive oral orodispersable clonazepam.

Arm Title

Buccal midazolam

Arm Type

Experimental

Arm Description

50 patients will receive buccal midazolam.

Arm Title

Conventional treatment

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Midazolam oral solution

Other Intervention Name(s)

midazolam

Intervention Description

Buccal administration

Intervention Type

Drug

Intervention Name(s)

ClonazePAM Oral Product

Other Intervention Name(s)

clonazepam

Intervention Description

Orodispersable

Intervention Type

Other

Intervention Name(s)

Usual medication/ traditional

Intervention Description

Medication that is usually used in the emergency department

Primary Outcome Measure Information:

Title

Change from baseline seizure frequency comparison using buccal midazolam, orodispersable clonazepam versus usual care efficacy for seizure clusters

Description

Seizure frequency description, using the Engel Score of Seizure Outcomes

Time Frame

1,3 and 6 months

Secondary Outcome Measure Information:

Title

Change from baseline seizure recurrence in 6 months

Description

Seizure frequency description, using the Engel Score of Seizure outcomes.

Time Frame

6 months

Title

Change from baseline quality of life assessed by the QOLIE-31 from baseline

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elma M Paredes-Aragón, MD

Phone

5556063822

Ext

1058

elma.paredes@innn.edu.mx

First Name & Middle Initial & Last Name or Official Title & Degree

Juan C Lopez Hernandez, MD

Phone

5556063822

Ext

1058

juanca9684@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elma M Paredes-Aragón, MD

Organizational Affiliation

National Institute of Neurology and Neurosurgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto Nacional de Neurología y Neurocirugía "Dr. Manuel Velasco Suárez"

City

Mexico City

State/Province

Cdmx

ZIP/Postal Code

14269

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elma M Paredes- Aragón, MD

Phone

55 5606 3822

Ext

1058

elma.paredes@innn.edu.mx

First Name & Middle Initial & Last Name & Degree

Juan Carlos Lopez Hernandez, MD

Phone

55 5606 3822

Ext

1058

juanca9684@hotmail.com

First Name & Middle Initial & Last Name & Degree

Mijail Rivas, MD

First Name & Middle Initial & Last Name & Degree

Mireille Salas, MD

First Name & Middle Initial & Last Name & Degree

Jonathan Macias Lopez, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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