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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cluster Seizure
• Intervention / Treatment: Drug: ClonazePAM Oral Product; Drug: Midazolam oral solution; Other: Usual medication/ traditional

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elma M Paredes-Aragón, MD; Phone Number: 1058 5556063822; Email: elma.paredes@innn.edu.mx
• Study Contact Backup: Name: Juan C Lopez Hernandez, MD; Phone Number: 1058 5556063822; Email: juanca9684@hotmail.com

Study Locations

• Mexico
  • Cdmx
    • Mexico City, Cdmx, Mexico, 14269
      • Recruiting
      • Instituto Nacional de Neurología y Neurocirugía "Dr. Manuel Velasco Suárez"
      • Contact: Elma M Paredes- Aragón, MD; Phone Number: 1058 55 5606 3822; Email: elma.paredes@innn.edu.mx
      • Contact: Juan Carlos Lopez Hernandez, MD; Phone Number: 1058 55 5606 3822; Email: juanca9684@hotmail.com
      • Sub-Investigator: Mijail Rivas, MD
      • Sub-Investigator: Mireille Salas, MD
      • Sub-Investigator: Jonathan Macias Lopez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
• Investigators: Principal Investigator: Elma M Paredes-Aragón, MD, National Institute of Neurology and Neurosurgery

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: epilepsy; benzodiazepines; rescue medication; seizure cluster
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Midazolam; Clonazepam
• Other Study ID Numbers: 05/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No