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

NCT06056349 | Recruiting DMC

• 1 other identifier: 05/23
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cluster Seizure

Keywords

seizure cluster; epilepsy; rescue medication; benzodiazepines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline seizure recurrence in 6 months

  6 months

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

  6 months

Study Arms (3)

Orodispersable clonazepam

EXPERIMENTAL

50 patients will receive oral orodispersable clonazepam.

Drug: ClonazePAM Oral Product

Buccal midazolam

EXPERIMENTAL

50 patients will receive buccal midazolam.

Drug: Midazolam oral solution

Conventional treatment

ACTIVE COMPARATOR

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

Other: Usual medication/ traditional

Interventions

Midazolam oral solution DRUG

Buccal administration

Also known as: midazolam

Buccal midazolam

ClonazePAM Oral Product DRUG

Orodispersable

Also known as: clonazepam

Orodispersable clonazepam

Usual medication/ traditional OTHER

Medication that is usually used in the emergency department

Conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez: lead

Study Sites (1)

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

Mexico City, Mexico City, 14269, Mexico

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Midazolam; Clonazepam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepinones

Study Officials

• Elma M Paredes-Aragón, MD

  National Institute of Neurology and Neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elma M Paredes-Aragón, MD

CONTACT

5556063822; elma.paredes@innn.edu.mx

Juan C Lopez Hernandez, MD

CONTACT

5556063822; juanca9684@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Neurologist, Epileptologist

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

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: September 28, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)