Verfied non convulsive status epilepticus refractory to standard treatment with benzodiazepines and at least one first line drug MedDRA version: 20.0 Level: PT Classification code 10041962 Term: Status epilepticus System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Briviract
Product Name: Briviracetam
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: Brivaracetam
Concentration unit: mg milligram(s)
Concentrat
Sponsors
Odense Universitetshospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults with EEG-verified NCSE without response to relevant treatment with benzodiazepines and at least one 2. line i.v. anti-epileptic drug according to the current national treatment guidelines Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: -SE due to cerebral infections -acute traumatic or spontaneous hemorrages -suspected cerebral anoxia after e.g. cardic arrest or similar conditions -contraindiations to treatment with anti-epileptic drugs according to the current national treatment guidelines (https://neuro.dk/wordpress/nnbv/) -contraindications to narcosis -fokal motor status epilepticus without relevant impairment of conciousness (Glasgow Coma Scale >13) -known epileptic encephalopathy -acute need of intubation due to other causes - known allergy against drugs used in the trial - known, proven or suspected pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine effecivity of rapid sedation with propofol/midazolam vs. treatment with intravenous anti-epileptic drug in patients with non-convulsive status epilepticus;Secondary Objective: •compare the influence of both treatments on new neurologic deficits •compare side effects of both treatments •analyse the influence of cEEG on treatment and outcome •effect of treatment on mortality and treatment-related complications •Economic analyses ;Primary end point(s): Primary endpoint is treatment failures defined as NCSE on the EEG 24 h after randomization. ;Timepoint(s) of evaluation of this end point: 24 hour after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Compare the influence of both treatments on new neurologic deficits • Compare side effects of both treatments • Analyse the influence of cEEG on treatment and outcome • Effect of treatment on mortality and treatment-related complications • Economic analyses ;Timepoint(s) of evaluation of this end point: During hospitalization | — |
Countries
Denmark
Contacts
Public ContactDepartment of Neurology
Odense Universitetshospital
Outcome results
None listed