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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orodispersable clonazepam | Experimental | 50 patients will receive oral orodispersable clonazepam. |
|
| Buccal midazolam | Experimental | 50 patients will receive buccal midazolam. |
|
| Conventional treatment | Active Comparator | 50 patients will receive "usual/ conventional treatment of seizure clusters" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam oral solution | Drug | Buccal administration |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elma M Paredes-Aragón, MD | Contact | 5556063822 | 1058 | elma.paredes@innn.edu.mx |
| Juan C Lopez Hernandez, MD | Contact | 5556063822 | 1058 | juanca9684@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Elma M Paredes-Aragón, MD | National Institute of Neurology and Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Neurología y Neurocirugía "Dr. Manuel Velasco Suárez" | Recruiting | Mexico City | Mexico City | 14269 | Mexico |
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This is an open label, randomnized, prospective clinical trial, with a 1:1:1 aleatorization of a single third level specialized neurological center.
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| ClonazePAM Oral Product | Drug | Orodispersable |
|
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| Usual medication/ traditional | Other | Medication that is usually used in the emergency department |
|
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 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D002998 | Clonazepam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001570 | Benzodiazepinones |
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