Clinical trial NCT02679846: Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring
Official title: Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: withdrawal of antiepileptic drugs
monitoring VEEG
safety
adverse event
standardized protocol
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 1567
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who develop seizure-related serious adverse events during long-term VEEG monitoring
timeFrame: from date of inclusion until end of study (maximum 36 days)
Secondary outcomes:
measure: Proportion of patients who develop each of the above seizure-related SAEs during long-term VEEG monitoring
timeFrame: from date of inclusion until end of study (maximum 36 days)
measure: Proportion of patients who develop SAEs unrelated to the occurrence of a seizure, during long-term VEEG monitoring
timeFrame: from date of inclusion until end of study (maximum 36 days)
measure: Proportion of patients who develop adverse events, including serious and non-serious adverse events, during long-term VEEG monitoring
timeFrame: from date of inclusion until end of study (maximum 36 days)
measure: Delay between onset of monitoring and VEEG recording of the first seizure (in hours)
timeFrame: from date of inclusion until the first seizure (maximum 21 days)
measure: Proportion of patients in whom at least one seizure will be recorded during the VEEG monitoring
timeFrame: from date of inclusion until the end of monitoring (maximum 21 days)
measure: Proportion of patients in whom the duration of VEEG monitoring will extend beyond its initially scheduled time limits
timeFrame: from date of inclusion until the end of monitoring (maximum 21 days)
measure: Duration of VEEG
timeFrame: from date of inclusion until the end of monitoring (maximum 21 days)
Other outcomes:
Locations:
city: Amiens
country: France
facility: Hôpital Nord
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: Hôpital R. Pellegrin
city: Bron
country: France
facility: Hôpital HFME
city: Bron
country: France
facility: Hôpital P. Wertheimer
city: Dijon
country: France
facility: Hôpital Général
city: Grenoble
country: France
facility: Hôpital Michallon
city: Lille
country: France
facility: Hôpital R. Salengro
city: Marseille
country: France
facility: Hôpital de La Timone
city: Montpellier
country: France
facility: Hôpital G. de Chauliac
city: Nancy
country: France
facility: Hôpital Central
city: Nice
country: France
facility: Hôpital Pasteur
city: Paris
country: France
facility: La Pitié Salpétrière
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Paris
country: France
facility: Hôpital Robert Debré
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: Hôpital Ch. Nicolle
city: St Etienne
country: France
facility: Hôpital Nord
city: Strasbourg
country: France
facility: Hôpital Hautepierre
city: Tain
country: France
facility: La Teppe
city: Toulouse
country: France
facility: Hôpital Paul Riquet
city: Tours
country: France
facility: CHU Bretonneau
Study officials:
affiliation: Service de Neurologie Fonctionnelle et d'Epileptologie et Institut des Epilepsies
name: Sylvain RHEIMS, MD
role: PRINCIPAL_INVESTIGATOR
References: