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

NCT01870024 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 434

Last updated 2018-10-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Clonazepam

clonazepam 0,015 mg/kg

DRUG

Fosphenytoin

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

DRUG

Placebo

placebo 20 mg/kg by intravenous infusion over a period of 15 minutes

DRUG

Lorazepam

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Papa GUEYE, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • François CONCINA, MD · CHU Toulouse - Hôpital Purpan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-26
Primary Completion
2018-02-23
Completion
2018-02-23

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01870024 on ClinicalTrials.gov