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

January 20, 2021 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1567

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • Hopital Nord
      • Angers, France
        • CHU d'Angers
      • Bordeaux, France, 33000
        • Hôpital R. Pellegrin
      • Bron, France, 69500
        • Hôpital HFME
      • Bron, France, 69677
        • Hôpital P. Wertheimer
      • Dijon, France, 21000
        • Hôpital Général
      • Grenoble, France, 38043
        • Hopital Michallon
      • Lille, France, 59037
        • Hopital R. Salengro
      • Marseille, France, 13385
        • Hôpital de La Timone
      • Montpellier, France, 34295
        • Hôpital G. de Chauliac
      • Nancy, France, 54035
        • Hôpital Central
      • Nice, France, 06000
        • Hopital PASTEUR
      • Paris, France, 75019
        • Hopital Robert Debre
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild
      • Paris, France, 75015
        • Hopital Necker
      • Paris, France, 75013
        • La Pitié Salpêtrière
      • Rennes, France, 35000
        • Hôpital Pontchaillou
      • Rouen, France, 76031
        • Hôpital Ch. Nicolle
      • St Etienne, France, 42055
        • Hopital Nord
      • Strasbourg, France, 67100
        • Hopital Hautepierre
      • Tain, France, 26602
        • La Teppe
      • Toulouse, France, 31059
        • Hôpital Paul Riquet
      • Tours, France, 37044
        • CHU Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who develop seizure-related serious adverse events during long-term VEEG monitoring
Time Frame: from date of inclusion until end of study (maximum 36 days)

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
Time Frame
Proportion of patients who develop each of the above seizure-related SAEs during long-term VEEG monitoring
Time Frame: from date of inclusion until end of study (maximum 36 days)
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
Time Frame: from date of inclusion until end of study (maximum 36 days)
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
Time Frame: from date of inclusion until end of study (maximum 36 days)
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)
Time Frame: from date of inclusion until the first seizure (maximum 21 days)
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
Time Frame: from date of inclusion until the end of monitoring (maximum 21 days)
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
Time Frame: from date of inclusion until the end of monitoring (maximum 21 days)
from date of inclusion until the end of monitoring (maximum 21 days)
Duration of VEEG
Time Frame: from date of inclusion until the end of monitoring (maximum 21 days)
from date of inclusion until the end of monitoring (maximum 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sylvain RHEIMS, MD, Service de Neurologie Fonctionnelle et d'Epileptologie et Institut des Epilepsies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2016

Primary Completion (Actual)

December 14, 2020

Study Completion (Actual)

December 14, 2020

Study Registration Dates

First Submitted

February 8, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-852
  • 2014-A01460-47 (Other Identifier: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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