Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring
NCT ID: NCT02679846
Last Updated: 2021-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1567 participants
INTERVENTIONAL
2016-02-19
2020-12-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Standardized protocol of AEDs withdrawal
The standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients
Standardized protocol
The standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients
Current practice
Centers will continue their current practice
No interventions assigned to this group
Interventions
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Standardized protocol
The standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients
Eligibility Criteria
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Inclusion Criteria
* 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
* Inpatient in one of the participating EMUs for performing short-term VEEG monitoring (\<48 hours)
* Pregnant or breastfeeding woman
6 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Sylvain RHEIMS, MD
Role: PRINCIPAL_INVESTIGATOR
Service de Neurologie Fonctionnelle et d'Epileptologie et Institut des Epilepsies
Locations
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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
La Pitié Salpétrière
Paris, , France
Hôpital Necker
Paris, , France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, , France
Hôpital Robert Debré
Paris, , France
Hôpital Pontchaillou
Rennes, , France
Hôpital Ch. Nicolle
Rouen, , France
Hôpital Nord
Saint-Etienne, , France
Hôpital Hautepierre
Strasbourg, , France
La Teppe
Tain-l'Hermitage, , France
Hôpital Paul Riquet
Toulouse, , France
CHU Bretonneau
Tours, , France
Countries
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Other Identifiers
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2014-A01460-47
Identifier Type: OTHER
Identifier Source: secondary_id
2014-852
Identifier Type: -
Identifier Source: org_study_id
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