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

Not Applicable

Recruiting

• Conditions: Cluster Seizure
• Interventions: Other: Usual medication/ traditional; Drug: ClonazePAM Oral Product; Drug: Midazolam oral solution

• Registration Number: NCT06056349
• Lead Sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

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.

Study Timeline

• Study First Submitted: 2023-04-25
• Study Start: 2023-05-01
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conventional treatment	Usual medication/ traditional	50 patients will receive "usual/ conventional treatment of seizure clusters"
Orodispersable clonazepam	ClonazePAM Oral Product	50 patients will receive oral orodispersable clonazepam.
Buccal midazolam	Midazolam oral solution	50 patients will receive buccal midazolam.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Instituto Nacional de Neurología y Neurocirugía "Dr. Manuel Velasco Suárez"; 🇲🇽 Mexico City, Cdmx, Mexico