Skip to main content
OpenTrials
Completed

NCT Number: NCT01150331

Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus

Compare the efficiency of the association, first line, the intravenous levetiracetam and the intravenous clonazepam, in that of a monotherapy of clonazepam intravenous in the pre-hospital treatment of tonicoclonic generalised status epilepticus.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Necker Hospital

Paris, 75015, France

About this study

At this time, the prehospital treatment of the status epilepticus use some molecule ("FOSPHENYLOINE") with large contra-indications. In this case the physician is not able to know the past medical history of the patient, the biological examinations and so he can not decide which molecules he can use.

The levetiracetam is a knowledge medication in the epilepsy since more than twenty years. One of specificity of the levetiracetam is to be able to be used in all situations (no clinical or biological contre-indication). This molecule seems like to be very interesting to be used in prehospital system.

The goal of this study is to evaluate the association levetiracetam / clonazepam in first line in the prehospital treatment of the status epilepticus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Patient taken care by a prehospital medical team participating in the study
  • Diagnosis of tonicoclonic generalized status epilepticus confirmed on the spot by a physician of the team.

Exclusion criteria

  • Parent or the reliable person indicated by the patient present not giving its agreement for the inclusion
  • Pregnancy clinically detectable or known for close relations at the time of the status epilepticus
  • tonicoclonic generalized status epilepticus after anoxia post cardiac arrest
  • Patient having already received another treatment for the same episode of status epilepticus
  • Patient having already participated in the study during a previous episode of status epilepticus
  • Patient in "latent" status epilepticus. Definition : patient in the coma having epileptic demonstrations (CLONISMS MYOCLONISMS) small or invalid, contrasting with permanent generalized electric seizures on the EEG
  • Patient presenting certain diagnosis of pseudo name psychogenic seizure
  • Patient whose neurological status requires an immediate surgery (traumatism)
  • Patient having a hyper-responsiveness about the levetiracetam or about the other by-products of pyrrolidone or an one of the excipients
  • Patient having a hyper-responsiveness about the clonazepam, about the benzodiazepins or about one of the other constituents of the product
  • Patient under medical guardianship
  • Not membership in a schema of medical assurance.

Treatment and study plan

Levetiracetam/Clonazepam

Drug

Association of two anti-epileptic drugs in first line

Other names: Association of two anti-epileptic drugs in first line

Clonazepam/Placebo levetiracetam IV

Drug

Association of placebo to an active comparator (clonazepam)

Other names: Association of placebo to an active comparator (clonazepam)

Primary outcomes

  1. Patient's percentage having stopped convulsing in the 15 minutes following the injection. The stop of the crisis is defined as the stop of all epileptic movements (myoclonic, clonic or tonic)

    Time frame: 15 minutes

Secondary outcomes

  1. Period between the first injection and the clinical stop of the convulsion

    Time frame: up to 15 minutes

  2. Period between the first injection and the presence of signs of awakening

    Time frame: up to three days

  3. Time of hospitalization

    Time frame: up to 15 days

  4. Patient's percentage having received the second injection of clonazepam to T5 min

    Time frame: 5 minutes

  5. Patient's percentage having received an injection of second anticonvulsivant to T15 min

    Time frame: 15 minutes

  6. Patient's percentage presenting signs of awakening to T35 min

    Time frame: 35 minutes

  7. Patient's percentage having been intubated for the general anesthesia

    Time frame: 35 minutes

  8. Score of glasgow coma scale for the patients with no signs of awakening to T35 and to the arrival of the hospital

    Time frame: up to 35 minutes

  9. Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up

    Time frame: up to 15 days

  10. Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital

    Time frame: up to 15 days

  11. Frequency of adverse events and their severity

    Time frame: up to 15 days

  12. Frequency of respiratory, hemodynamic and cardiac occurence of complications

    Time frame: up to 15 days

  13. Analysis of the main criteria of efficiency by sous groups according to the etiology of the generalised tonic-clonic status epilepticus and according to this duration during the therapeutic clinical care

    Time frame: up to 15 days

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Efficiency of Levetiracetam Intravenous in Association With Clonazepam Versus Clonazepam Alone in Prehospital Care of Generalised Tonicoclonic Status Epilepticus

Acronym: SAMU-KEPPRA

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 24, 2010
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.