Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring (SAVE)

Civil Hospices of Lyon

Status

Completed

Conditions

Epilepsy

Treatments

Other: Standardized protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT02679846

2014-A01460-47 (Other Identifier)

2014-852

Details and patient eligibility

About

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.

Enrollment

1,567 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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