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Reducing antiepileptic medication during a multiple-day video-EEG to investigate the feasibility of epilepsy surgery: what is the best way (safest and most efficious) to reduce antiepileptic drugs?


- candidate number27570
- NTR NumberNTR6623
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jul-2017
- Secondary IDsMETC 17-157/C METC UMC Utrecht
- Public TitleReducing antiepileptic medication during a multiple-day video-EEG to investigate the feasibility of epilepsy surgery: what is the best way (safest and most efficious) to reduce antiepileptic drugs?
- Scientific TitleThe NeedToStop study. Antiepileptic drug withdrawal in long-term video-EEG monitoring for pre-surgical evaluation: a European safety and efficacy analysis
- ACRONYMNeedToStop
- hypothesisCombining factors will enable prediction of successful long-term video-EEG monitoring and of adverse effects, related to antiepileptic drug withdrawal.
- Healt Condition(s) or Problem(s) studiedEpilepsy, Antiepileptics, Surgery
- Inclusion criteria- Long-term video-EEG monitoring (LTM) is initiated in the evaluation for epilepsy surgery (all ages)
- Informed consent signed. In case of age below 16, both parents sign informed consent. For the ages 12-15 (by Dutch law, may be different per country), the child and both parents sign. If they do not, the patient will not participate.
- Exclusion criteria- intracranial long-term monitoring (subdural grid or depth/stereo-EEG)
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 10-apr-2017
- planned closingdate1-mrt-2020
- Target number of participants850
- InterventionsNot applicable
- Primary outcomePredictors of efficacy: A sufficient number of habitual seizures have been recorded.
Predictors of safety: presence of complications, defined as any of the following: status epilepticus (defined as a seizure lasting 5 minutes), seizure clustering ( 3 seizures in 4 hours), falls and physical injuries, postictal psychosis, generalized tonic-clonic seizures in patients without prior occurrence of these, cardio-respiratory distress, or acute medical complications requiring intervention
- Secondary outcome- The proportion of patients with AED tapering.
- Baseline differences between patients with and patients without AED tapering
- Efficacy comparison between patients with and patients without AED tapering
- Safety comparison between patients with and patients without AED tapering
- Effects of AED withdrawal and restart of AEDs on seizure frequency and cognitive and emotional functioning in the weeks after LTM
- TimepointsBaseline, during LTM and four weeks after
- Trial web siteNot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES HJ Lamberink
- CONTACT for SCIENTIFIC QUERIES HJ Lamberink
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Epilepsiefonds
- Publications
- Brief summaryRationale: In people with refractory epilepsy, long-term video-EEG monitoring (LTM) is a valuable tool to evaluate eligibility for epilepsy surgery. For many patients, anti-epileptic drugs (AEDs) are tapered during LTM, but safety concerns have been raised. AED withdrawal might be related to increased complications among which status epilepticus, whilst efficacy has not been established.
Objective: to study the safety and efficacy of AED withdrawal in LTM.
Study design: prospective observational multi-centre study
Study population: children and adults undergoing LTM in the evaluation for epilepsy surgery.
Main study parameters/endpoints: the efficacy endpoint is reached when a sufficient number of habitual seizures have been recorded. Safety is defined by the presence of complications, with any of the following items: status epilepticus (defined as a seizure lasting 5 minutes), seizure clustering ( 3 seizures in 4 hours), falls and physical injuries, postictal psychosis, generalized tonic-clonic seizures in patients without prior occurrence of these, cardio-respiratory distress, or acute medical complications requiring intervention.
- Main changes (audit trail)
- RECORD20-jul-2017 - 20-aug-2017


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