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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679846
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Epilepsy Other: Standardized protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring
Actual Study Start Date : February 19, 2016
Estimated Primary Completion Date : September 19, 2020
Estimated Study Completion Date : September 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. Duration of VEEG [ Time Frame: from date of inclusion until the end of monitoring (maximum 21 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679846


Contacts
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Contact: Sylvain RHEIMS, MD 4 72 35 70 44 ext +33 sylvain.rheims@chu-lyon.fr
Contact: Anne-Laure CHARLOIS 4 72 11 80 70 ext +33 anne-laure.charlois@chu-lyon.fr

Locations
Show Show 23 study locations
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Sylvain RHEIMS, MD Service de Neurologie Fonctionnelle et d'Epileptologie et Institut des Epilepsies

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02679846    
Other Study ID Numbers: 2014-852
2014-A01460-47 ( Other Identifier: ID-RCB )
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Keywords provided by Hospices Civils de Lyon:
withdrawal of antiepileptic drugs
monitoring VEEG
safety
adverse event
standardized protocol
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants