Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring

Epilepsy Clinical Trial

— SAVE  

Official title:

Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679846
• Other study ID #: 2014-852
• Secondary ID: 2014-A01460-47
• Status: Completed
• Phase: N/A
• Start date: February 19, 2016
• Est. completion date: December 14, 2020

Study information

• Verified date: January 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1567
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Standardized protocol
The standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients

Locations

Country	Name	City	State
France	Hôpital Nord	Amiens
France	CHU d'Angers	Angers
France	Hôpital R. Pellegrin	Bordeaux
France	Hôpital HFME	Bron
France	Hôpital P. Wertheimer	Bron
France	Hôpital Général	Dijon
France	Hôpital Michallon	Grenoble
France	Hôpital R. Salengro	Lille
France	Hôpital de La Timone	Marseille
France	Hôpital G. de Chauliac	Montpellier
France	Hôpital Central	Nancy
France	Hôpital Pasteur	Nice
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	Hôpital Necker	Paris
France	Hôpital Robert Debré	Paris
France	La Pitié Salpétrière	Paris
France	Hôpital Pontchaillou	Rennes
France	Hôpital Ch. Nicolle	Rouen
France	Hôpital Nord	St Etienne
France	Hôpital Hautepierre	Strasbourg
France	La Teppe	Tain
France	Hôpital Paul Riquet	Toulouse
France	CHU Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Duration of VEEG		from date of inclusion until the end of monitoring (maximum 21 days)