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Status EpilepticusPhase 3LORACLOFTNCT01870024

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

A Phase 3 study testing Clonazepam, Fosphenytoin and Lorazepam in people with Status Epilepticus and Epilepsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Status Epilepticus, Epilepsy
What is being tested?
Clonazepam, Fosphenytoin and Lorazepam
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
434 participants
Where
1 siteFrance
Study dates
26 Jun 2013to 23 Feb 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
  • if they were having more than 2 repeated convulsive seizures at the time of treatment without regaining consciousness

Who cannot join

  • 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
Show all 21Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Département d'Anesthésie - Réanimation - SMUR - Hôpital Lariboisière

    Paris, 75010

Other trials in France

About this study

Official title: Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus in Adults Patients

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.

Read the detailed description

Background: Early and rapid termination of status epilepticus with intravenous administration of benzodiazepines only or its association with other antiepileptic drug improves outcomes. Our out-of-hospital study aims to demonstrate on one hand the superiority of lorazepam compared with clonazepam and on the other hand the efficacy at least equivalent of lorazepam in comparison with the association clonazepam + fosphenytoin. If these hypotheses are demonstrated, the out-of-hospital treatment of the status epilepticus by lorazepam in monotherapy would then be strongly recommended, considering its efficacy and the simplicity of administration in the context of the pre-hospital emergency.Objective: To compare the efficacy of Lorazepam with that of Clonazepam and its association with Fosphenytoin for the treatment of out-of-hospital status epilepticus.

Participating centers: 41 prehospital emergency services employing mobile intensive care units and located in urban areas in France participated in this study. In France, the management of out-of-hospital medical emergencies is under the responsibility of the Service d'Aide Medicale Urgente (SAMU). Mobile intensive care units are staffed by an attending emergency physician or anesthesiologist, a nurse, and an ambulance driver. The study is coordinated by the prehospital emergency service of Lariboisiere Hospital, University Paris 7 (Paris, France)

Number of patients: 522 patients; 174 patients by group.

Duration of the study: The total duration planned is of 48 months Intermediate analysis: An intermediate analysis is planned while 261 patients will be included (50 % of the inclusions).Duration of participation of every patient: 24 hours Data collection: prehospital data recording during the 60 min period of the study, and intrahospital data recording by the medical report of hospitalization.

Methodology: Multicenter, randomized, double-blind trial with 3 arms.

Main criteria of evaluation: the cessation of the status epilepticus and the absence of recurrence from T20 minutes until T60 minutes after the beginning of the treatment.

The cessation of the status epilepticus is defined by the stop of any motor activity and any seizures or convulsive movements. The absence of recurrence is defined by the not occurrence of a new seizures after a period of cessation.

Being tested
Clonazepam, Fosphenytoin, Placebo, Lorazepam
Keywords
status epilepticus, epilepsy, seizures, convulsive seizures, convulsions, benzodiazepines, anticonvulsants
Medical subject headings
Status Epilepticus, Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClonazepamDrug

    clonazepam 0,015 mg/kg

  • FosphenytoinDrug

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

  • PlaceboDrug

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

  • LorazepamDrug

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

Study groups in NCT01870024
Study groupRoleWhat they receive
1: Lorazepam + PlaceboActive comparator[ 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
Receives: Drug: Placebo; Drug: Lorazepam
2: Clonazepam + PlaceboActive comparator[ 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
Receives: Drug: Clonazepam; Drug: Placebo
3: Clonazepam + FosphenytoinActive comparator[ 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
Receives: Drug: Clonazepam; Drug: Fosphenytoin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patient with a cessation of seizures and absence of recurrence

    Percentage of patient with a cessation of seizures and absence of recurrence from 20 minutes until 60 minutes after the beginning of the treatment

    Measured: between 20 and 60 minutes after the beginning of the treatment

Secondary outcomes (11)

  1. Duration between the first cessation and the recurrence of seizures

    Duration between the first cessation and the recurrence of seizures

    Measured: up to 60 minutes

  2. Percentage of patients having had a second injection of benzodiazepine

    Percentage of patients having had a second injection of benzodiazepine

    Measured: up to 60 minutes

  3. Percentage of patients having had an injection of the second line treatment

    Percentage of patients having had an injection of the second line treatment (i.e. Fosphenytoin or barbiturate)

    Measured: up to 60 minutes

  4. Percentage of patients having a general anesthesia for refractory status epilepticus

    Percentage of patients having a general anesthesia for refractory status epilepticus

    Measured: up to 60 minutes

  5. Percentage of patients having had a side effect

    Percentage of patients having had a side effect (low blood pressure, arrhythmias)

    Measured: up to 60 minutes

  6. Percentage of patients having been mechanically ventilated

    Percentage of patients having been mechanically ventilated in pre-hospital setting

    Measured: up to 60 minutes

  7. Glasgow Coma Scale

    Glasgow Coma Scale on arrival at the hospital

    Measured: 60 minutes

  8. Mortality

    Mortality in pre-hospital setting

    Measured: up to 60 minutes

  9. Mortality

    Mortality in hospital until J30 (if the patient still hospitalized)

    Measured: up to Day 30

  10. Length of stay in Intensive Care Unit

    Length of stay in Intensive Care Unit

    Measured: up to Day 30

  11. Length of stay in hospital

    Length of stay in hospital

    Measured: up to Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2013 (estimated)
  2. Study start26 Jun 2013
  3. Primary completion23 Feb 2018
  4. Study completion23 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
434 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01870024
Sponsor's protocol ID
P110123
Other IDs
2012-003795-39
Acronym
LORACLOFT
Status last verified
Oct 2018
First submitted
3 Jun 2013
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clonazepam, Fosphenytoin and Lorazepam in people with Status Epilepticus and Epilepsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patient with a cessation of seizures and absence of recurrence (time frame: between 20 and 60 minutes after the beginning of the treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01870024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.

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