Aggressive or less aggressive treatment of persistent epileptic seizures

Phase 1

• Conditions: Verfied non convulsive status epilepticus refractory to standard treatment with benzodiazepines and at least one first line drug; MedDRA version: 20.0Level: PTClassification code 10041962Term: Status epilepticusSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-003392-34-DK
• Lead Sponsor: Odense Universitetshospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-17
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 ;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<br>•compare side effects of both treatments<br>•analyse the influence of cEEG on treatment and outcome<br>•effect of treatment on mortality and treatment-related complications<br>•Economic analyses<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Compare the influence of both treatments on new neurologic deficits<br>•Compare side effects of both treatments<br>•Analyse the influence of cEEG on treatment and outcome<br>•Effect of treatment on mortality and treatment-related complications<br>•Economic analyses<br>;Timepoint(s) of evaluation of this end point: During hospitalization