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Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus (SAMU-KEPPRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01150331
Recruitment Status : Completed
First Posted : June 24, 2010
Last Update Posted : June 23, 2014
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Status; Epilepticus, Tonic-clonic Drug: Levetiracetam/Clonazepam Drug: Clonazepam/Placebo levetiracetam IV Phase 3

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficiency of Levetiracetam Intravenous in Association With Clonazepam Versus Clonazepam Alone in Prehospital Care of Generalised Tonicoclonic Status Epilepticus
Study Start Date : July 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Clonazepam + levetiracetam
Clonazepam IV 1 mg+ levetiracetam IV 2500 mg
Drug: Levetiracetam/Clonazepam
Association of two anti-epileptic drugs in first line
Other Name: Association of two anti-epileptic drugs in first line

Active Comparator: Clonazepam + placebo
Clonazepam IV 1 mg + placebo levetiracetam IV
Drug: Clonazepam/Placebo levetiracetam IV
Association of placebo to an active comparator (clonazepam)
Other Name: Association of placebo to an active comparator (clonazepam)

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01150331

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Necker Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Study Chair: Pierre Carli, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01150331    
Other Study ID Numbers: P070704
First Posted: June 24, 2010    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Keywords provided by Assistance Publique - Hôpitaux de Paris:
status epilepticus
generalised convulsive status epilepticus
first line treatments
double-blind randomized controlled trial
prehospital treatment
Additional relevant MeSH terms:
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Status Epilepticus
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nootropic Agents
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs