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Status Epilepticus | Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus

Status Epilepticus research study

What is the primary objective of this study?

The main purpose of this study is to know on one hand if lorazepam is more (effective) than clonazepam and on the other hand if lorazepam is also effective as the association clonazepam + fosphenytoin in out-of-hospital treatment of the generalized convulsive status epilepticus in adult patients.

Who is eligible to participate?

Inclusion Criteria: - Patients aged 18 years or older - Out-of-hospital management - presenting one of the criteria below noticed by the physician of the mobile intensive care unit: 1. convulsive seizures at the time of treatment and were reported by reliable witnesses to have been continuously convulsing for longer than 5 minutes, without regaining consciousness, or 2. if they were having more than 2 repeated convulsive seizures at the time of treatment without regaining consciousness Exclusion Criteria: - Patient having been already included in the study during a previous episode of status epilepticus - Patient having already received before the arrival of the mobile intensive care unit one of theses studied drugs (lorazepam, clonazepam or fosphenytoin or phenytoin) - Latent status epilepticus in deep coma - Cerebral anoxia (post cardio respiratory arrest) - Severe head trauma - Patient presenting convulsive seizures of psychogenic origin - Lennox Gastaut's syndrome - Decision of urgent intubation - Patients of more than 110 kg ( estimated weight - Heart rate < 60 bpm or > 150 bpm - Systolic Blood Pressure < 90 mmHg - Atrioventricular block of 2nd or 3rd degree - Ventricular tachycardia or ventricular fibrillation - Sensibility known about benzodiazepines, fosphenytoin, phenytoin, other hydantoins, or barbiturate - Contraindication known about benzodiazepines (severe respiratory failure, severe acute hepatic failure, myasthenia, syndrome of sleep apnea, glaucoma with closed angle - Contraindication known about fosphenytoin (intermittent acute porphyry) - Contraindication known about barbiturate (porphyry, severe respiratory failure, current treatment by saquinavir, ifosfamide and voriconazole, in association with millepertuis) - Person unaffiliated in a National Social Security Insurance - Pregnant or breast-feeding Woman - Impossibility to put an intravenous or intra-osseous catheter for the treatment injection - Absence of nurse in the mobile intensive care unit.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Status Epilepticus

Epilepsy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Clonazepamclonazepam 0,015 mg/kg

Drug:Fosphenytoinfosphenytoin 20 mg/kg Equivalent Phenytoin (EP) by intravenous infusion over a period of 15 minutes

Drug:Placeboplacebo 20 mg/kg by intravenous infusion over a period of 15 minutes

Drug:Lorazepamlorazepam 0,1mg/kg by intravenous injection over a period of 2 to 3 minutes)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1: Lorazepam + Placebo[ L + P ] = lorazepam 0,1mg/kg by intravenous injection over a period of 2 to 3 minutes) + placebo 20 mg/kg by intravenous infusion over a period of 15 minutes

2: Clonazepam + Placebo[ C + P ] = clonazepam 0,015 mg/kg by intravenous injection over a period of 2 to 3 minutes + placebo 20 mg/kg by intravenous infusion over a period of 2 15 minutes

3: Clonazepam + Fosphenytoin[ C + F ] = clonazepam 0,015 mg/kg by intravenous injection over a period of 2 to 3 minutes + fosphenytoin 20 mg/kg Equivalent Phenytoin (EP) by intravenous infusion over a period of 15 minutes

Study Status

Recruiting

Start Date: June 2013

Completed Date: June 2017

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Percentage of patient with a cessation of seizures and absence of recurrence

Secondary Outcome: Duration between the first cessation and the recurrence of seizures

Study sponsors, principal investigator, and references

Principal Investigator: Papa GUEYE, MD, PhD

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01870024

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