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Lorazepam vs Clonazepam vs Clonazepam + Fosphenytoin in Out-of-hospital Status Epilepticus
NCT01870024Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2013
- Primary completion
- Feb 2018
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Small Molecules
- Drugs
- lorazepam
- Conditions
- generalized convulsive status epilepticus (GCSE)
01
Overview
Phase 3, randomised, double-blind trial of lorazepam in generalized convulsive status epilepticus (GCSE), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Percentage of patient with a cessation of seizures and absence of recurrence. Started Jun 2013; status: completed.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Adult patients with out-of-hospital generalized convulsive status epilepticus (continuous seizures > 5 min or > 2 seizures without recovery). Excludes patients with deep coma, cerebral anoxia, severe head trauma, psychogenic seizures, Lennox-Gastaut syndrome, or need for urgent intubation.
04
Endpoints
Primary
Percentage of patient with a cessation of seizures and absence of recurrence
Secondary
Duration between the first cessation and the recurrence of seizures
Percentage of patients having had a second injection of benzodiazepine
Percentage of patients having had an injection of the second line treatment
Percentage of patients having a general anesthesia for refractory status epilepticus
Percentage of patients having had a side effect
Percentage of patients having been mechanically ventilated
Glasgow Coma Scale
Mortality
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