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Treatment of Established Status Epilepticus in the Elderly - a prospective, randomized, double-blind comparative effectiveness trial
EU CTIS ID: 2024-516634-35-00
What this study is testing
Primary goal is to generate evidence for the treatment of established SE in an elderly population.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients ≥ 65 years old with ongoing convulsive SE (generalized CSE/focal CSE with impaired consciousness/focal CSE without impaired consciousness), as defined by a seizure lasting ≥ 5 minutes or 2 or more convulsive seizures without full recovery of consciousness ≥ 5 minutes, or nonconvulsive SE (NCSE with coma/ NCSE without coma) defined as ongoing EEG patterns consistent with definite or possible NCSE according to the Salzburg criteria (Leitinger et al. 2016), or clinically defined NCSE non-responding to treatment with AT LEAST • Lorazepam 2 mg (i.v.) • Midazolam 5 mg (i.v., buccal, intranasal, i.m.) • Diazepam 5 mg (i.v., rectal) • Clonazepam 1 mg (i.v.)
You likely can't join if
- • Treatment of SE with other antiepileptic drugs/sedatives before enrollment • Intravenous application of VPA or LEV in the last 24 hours before enrollment. • Known or suspected severe liver or pancreatic disease (alcohol addiction, known liver cirrhosis or familial liver diseases, clinical signs of severe liver disease such as ascites, jaundice) • Known concomitant treatment with one or several of the following medications: phenobarbital, phenytoin, carbamazepine, carbapenem antibiotics, rifampicin, erythromycin, cimetidine, primidone, mefloquine, fluoxetine, felbamat, lopinavir, ritonavir • Known coagulopathy (anticoagulants allowed) • Known porphyria, mitochondriopathy and urea cycle disorders • Known severe kidney disease (GFR < 30ml/min) • Hypoglycemia (< 3.3 mmol/l) • Estimated weight < 45kg. • Need for acute neurosurgical treatment. • Known cardiopulmonary resuscitation within the last 7 days before enrollment • Known hypersensitivity against VPA or LEV • Known participation in other interventional trials • Known former participation in this trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.