EpilepsySAVENCT02679846
Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring
A study testing Standardized protocol in people with Epilepsy, run by Hospices Civils de Lyon at 23 sites in France.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Standardized protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,567 participants
- Where
- 23 sitesFrance
- Study dates
- 19 Feb 2016to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age < 6 years old
- Inpatient in one of the participating EMUs for performing short-term VEEG monitoring (<48 hours)
- Pregnant or breastfeeding woman
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
Hôpital Nord
Amiens, 80054
CHU d'Angers
Angers
Hôpital R. Pellegrin
Bordeaux, 33000
Hôpital HFME
Bron, 69500
Hôpital P. Wertheimer
Bron, 69677
Hôpital Général
Dijon, 21000
Hôpital Michallon
Grenoble, 38043
Hôpital R. Salengro
Lille, 59037
Hôpital de La Timone
Marseille, 13385
Hôpital G. de Chauliac
Montpellier, 34295
Hôpital Central
Nancy, 54035
Hôpital Pasteur
Nice, 06000
La Pitié Salpétrière
Paris, 75013
Hôpital Necker
Paris, 75015
Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
Hôpital Robert Debré
Paris, 75019
Hôpital Pontchaillou
Rennes, 35000
Hôpital Ch. Nicolle
Rouen, 76031
Hôpital Nord
Saint-Etienne, 42055
Hôpital Hautepierre
Strasbourg, 67100
La Teppe
Tain-l'Hermitage, 26602
Hôpital Paul Riquet
Toulouse, 31059
CHU Bretonneau
Tours, 37044
About this study
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.
Read more
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
- Being tested
- Standardized protocol
- Keywords
- withdrawal of antiepileptic drugs, monitoring VEEG, safety, adverse event, standardized protocol
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized protocolOther
The standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients
| Study group | Role | What they receive |
|---|---|---|
| Standardized protocol of AEDs withdrawal | Experimental | The standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients Receives: Other: Standardized protocol |
| Current practice | No intervention | Centers will continue their current practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: from date of inclusion until the end of monitoring (maximum 21 days)
Duration of VEEG
Measured: from date of inclusion until the end of monitoring (maximum 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study start19 Feb 2016
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain RHEIMS, MD, Principal investigator, Service de Neurologie Fonctionnelle et d'Epileptologie et Institut des Epilepsies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679846
- Sponsor's protocol ID
- 2014-852
- Other IDs
- 2014-A01460-47
- Acronym
- SAVE
- Status last verified
- Jan 2021
- First submitted
- 8 Feb 2016
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring
- ClinicalTrials.gov ID
- NCT02679846
- Acronym / sponsor ID
- SAVE / 2014-852
- Conditions
- Epilepsy
- Keywords
- withdrawal of antiepileptic drugs, monitoring VEEG, safety, adverse event, standardized protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,567 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized protocol of AEDs withdrawal | Experimental | Other: Standardized protocolThe standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients |
| Current practice | No intervention | –Centers will continue their current practice |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 6 years old
- Inpatient in one of the participating EMUs for performing short-term VEEG monitoring (<48 hours)
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized protocolThe standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients | Other | Standardized protocol of AEDs withdrawal |
Primary outcome
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
7 secondary outcomes
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)
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)
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)
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)
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)
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)
Duration of VEEG
Time frame: from date of inclusion until the end of monitoring (maximum 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain RHEIMS, MD principal investigator
Service de Neurologie Fonctionnelle et d'Epileptologie et Institut des Epilepsies
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized protocol in people with Epilepsy, run by Hospices Civils de Lyon at 23 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.