Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring

Study Overview
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Brief Summary
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SAVE is a stratified cluster-randomised controlled, parallel group, open-label trial, with Epileptic Monitoring Unit (EMU) as the units of randomisation and patients as the unit of analysis. The focus of research is the management of AntiEpileptic Drugs (AEDs) withdrawal during long term Video EEG (VEEG) monitoring in patients with drug resistant seizures. This non-standardised medical practice, which aims at promoting the occurrence of seizures during the time limit of the monitoring period, exposes patients to significant risks which should be minimised by harmonisation of practice and a standardised protocol of AEDs withdrawal. SAVE will assess the impact of a standardised protocol of AEDs withdrawal during long-term VEEG monitoring on the frequency of seizure-related serious adverse events occurring during these monitorings and on the ability to obtain VEEG recording of seizures within appropriate time limits. 10 of the 22 EMUs will be randomised to the group where the standardised protocol of AEDs withdrawal will be used systematically, while the other ten EMUs will continue their current non-standardised practice of AEDs withdrawal, and will serve as a control group. The setting of the study will include a 6 months evaluation phase, prior to randomisation, during which the organisational characteristics, baseline EMUs' activity, current management of AEDs withdrawal, and rate of Serious Adverse Events (SAEs) of each participating center will be evaluated. The standardised study protocol of AEDs withdrawal has been defined on the basis of a systematic review of all relevant publications in the field.

Official Title
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Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring

Conditions
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Epilepsy

Intervention / Treatment
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* Other: Standardized protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female suffering from drug-resistant epilepsy Age ≥ 6 years old Inpatient in one of the participating EMUs for recording seizure during long-term VEEG monitoring (≥ 48 hours) Patient who gave its written informed consent to participate to the study, or for children, whose minimum one of parents had given its written informed consent Exclusion Criteria: Age < 6 years old Inpatient in one of the participating EMUs for performing short-term VEEG monitoring (<48 hours) Pregnant or breastfeeding woman

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized protocol of AEDs withdrawal<br>The standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients | Other: Standardized protocol<br>* The standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients<br>|
| No Intervention: Current practice<br>Centers will continue their current practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who develop seizure-related serious adverse events during long-term VEEG monitoring | Proportion of patients who develop seizure-related serious adverse events during long-term VEEG monitoring, defined as the occurrence of one or more of the following events: Convulsive or non-convulsive status epilepticus 4-hour seizure cluster (≥ 3 seizures / 4 hours) secondarily generalised seizure unusual for the patient (≤ 1/year) vertebral compression other fracture (including broken tooth) post-ictal psychosis post-ictal aspiration pneumonia cardio-respiratory arrest Any other seizure-related serious injury or adverse events | from date of inclusion until end of study (maximum 36 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who develop each of the above seizure-related SAEs during long-term VEEG monitoring |  | from date of inclusion until end of study (maximum 36 days) | 
| Proportion of patients who develop SAEs unrelated to the occurrence of a seizure, during long-term VEEG monitoring |  | from date of inclusion until end of study (maximum 36 days) | 
| Proportion of patients who develop adverse events, including serious and non-serious adverse events, during long-term VEEG monitoring |  | from date of inclusion until end of study (maximum 36 days) | 
| Delay between onset of monitoring and VEEG recording of the first seizure (in hours) |  | from date of inclusion until the first seizure (maximum 21 days) | 
| Proportion of patients in whom at least one seizure will be recorded during the VEEG monitoring |  | from date of inclusion until the end of monitoring (maximum 21 days) | 
| Proportion of patients in whom the duration of VEEG monitoring will extend beyond its initially scheduled time limits |  | from date of inclusion until the end of monitoring (maximum 21 days) | 
| Duration of VEEG |  | from date of inclusion until the end of monitoring (maximum 21 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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withdrawal of antiepileptic drugs, monitoring VEEG, safety, adverse event, standardized protocol