Cluster Seizure
Conditions
Keywords
seizure cluster, epilepsy, rescue medication, benzodiazepines
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.
Interventions
Buccal administration
DRUGClonazePAM Oral Product
Orodispersable
OTHERUsual medication/ traditional
Medication that is usually used in the emergency department
Sponsors
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Mexico
Contacts
Primary ContactElma M Paredes-Aragón, MD
Backup ContactJuan C Lopez Hernandez, MD
Outcome results
None listed