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

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

Study Overview

• Status: Completed
• Conditions: Status; Epilepticus, Tonic-clonic
• Intervention / Treatment: Drug: Levetiracetam/Clonazepam; Drug: Clonazepam/Placebo levetiracetam IV

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

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Necker Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Association of placebo to an active comparator (clonazepam)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	15 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Period between the first injection and the clinical stop of the convulsion	up to 15 minutes
Period between the first injection and the presence of signs of awakening	up to three days
Time of hospitalization	up to 15 days
Patient's percentage having received the second injection of clonazepam to T5 min	5 minutes
Patient's percentage having received an injection of second anticonvulsivant to T15 min	15 minutes
Patient's percentage presenting signs of awakening to T35 min	35 minutes
Patient's percentage having been intubated for the general anesthesia	35 minutes
Score of glasgow coma scale for the patients with no signs of awakening to T35 and to the arrival of the hospital	up to 35 minutes
Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up	up to 15 days
Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital	up to 15 days
Frequency of adverse events and their severity	up to 15 days
Frequency of respiratory, hemodynamic and cardiac occurence of complications	up to 15 days
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	up to 15 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Pierre Carli, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Navarro V, Dagron C, Demeret S, An K, Lamhaut L, Bolgert F, Baulac M, Carli P. A prehospital randomized trial in convulsive status epilepticus. Epilepsia. 2011 Oct;52 Suppl 8:48-9. doi: 10.1111/j.1528-1167.2011.03236.x.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: June 23, 2010
• First Posted (Estimate): June 24, 2010

Study Record Updates

• Last Update Posted (Estimate): June 23, 2014
• Last Update Submitted That Met QC Criteria: June 20, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: status epilepticus; double-blind randomized controlled trial; generalised convulsive status epilepticus; first line treatments; prehospital treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Status Epilepticus; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; GABA Modulators; GABA Agents; Nootropic Agents; Anticonvulsants; Levetiracetam; Clonazepam
• Other Study ID Numbers: P070704