Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring

NCT02679846 | Completed

• 2 other identifiers: 2014-8522014-A01460-47
• Study Type: interventional
• Target: 1,567
• Locations: 1 country
• Sites: 23

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.

Conditions

Epilepsy

Keywords

withdrawal of antiepileptic drugs; monitoring VEEG; safety; adverse event; standardized protocol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

Study Arms (2)

Standardized protocol of AEDs withdrawal

EXPERIMENTAL

The standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients

Other: Standardized protocol

Current practice

NO INTERVENTION

Centers will continue their current practice

Interventions

Standardized protocol OTHER

The standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients

Standardized protocol of AEDs withdrawal

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 6 years old
• Inpatient in one of the participating EMUs for performing short-term VEEG monitoring (\<48 hours)
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (23)

Hôpital Nord

Amiens, 80054, France

Location

CHU d'Angers

Angers, France

Location

Hôpital R. Pellegrin

Bordeaux, 33000, France

Location

Hôpital HFME

Bron, 69500, France

Location

Hôpital P. Wertheimer

Bron, 69677, France

Location

Hôpital Général

Dijon, 21000, France

Location

Hôpital Michallon

Grenoble, 38043, France

Location

Hôpital R. Salengro

Lille, 59037, France

Location

Hôpital de La Timone

Marseille, 13385, France

Location

Hôpital G. de Chauliac

Montpellier, 34295, France

Location

Hôpital Central

Nancy, 54035, France

Location

Hôpital Pasteur

Nice, 06000, France

Location

La Pitié Salpétrière

Paris, 75013, France

Location

Hôpital Necker

Paris, 75015, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

Hôpital Pontchaillou

Rennes, 35000, France

Location

Hôpital Ch. Nicolle

Rouen, 76031, France

Location

Hôpital Nord

Saint-Etienne, 42055, France

Location

Hôpital Hautepierre

Strasbourg, 67100, France

Location

La Teppe

Tain-l'Hermitage, 26602, France

Location

Hôpital Paul Riquet

Toulouse, 31059, France

Location

CHU Bretonneau

Tours, 37044, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sylvain RHEIMS, MD

  Service de Neurologie Fonctionnelle et d'Epileptologie et Institut des Epilepsies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 10, 2016
• Study Start: February 19, 2016
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

FR (23)