Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus

NCT ID: NCT01150331

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-10-31

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.

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

Conditions

Status; Epilepticus, Tonic-clonic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Clonazepam + levetiracetam

Clonazepam IV 1 mg+ levetiracetam IV 2500 mg

Group Type: EXPERIMENTAL

Levetiracetam/Clonazepam

Intervention Type: DRUG

Association of two anti-epileptic drugs in first line

Clonazepam + placebo

Clonazepam IV 1 mg + placebo levetiracetam IV

Group Type: ACTIVE_COMPARATOR

Clonazepam/Placebo levetiracetam IV

Intervention Type: DRUG

Association of placebo to an active comparator (clonazepam)

Interventions

Levetiracetam/Clonazepam

Association of two anti-epileptic drugs in first line

Intervention Type: DRUG

Clonazepam/Placebo levetiracetam IV

Association of placebo to an active comparator (clonazepam)

Intervention Type: DRUG

Other Intervention Names

Association of two anti-epileptic drugs in first line; Association of placebo to an active comparator (clonazepam)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Carli, MD, PhD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Locations

Necker Hospital

Paris, , France

Countries

France

References

Navarro V, Dagron C, Elie C, Lamhaut L, Demeret S, Urien S, An K, Bolgert F, Treluyer JM, Baulac M, Carli P; SAMUKeppra investigators. Prehospital treatment with levetiracetam plus clonazepam or placebo plus clonazepam in status epilepticus (SAMUKeppra): a randomised, double-blind, phase 3 trial. Lancet Neurol. 2016 Jan;15(1):47-55. doi: 10.1016/S1474-4422(15)00296-3. Epub 2015 Nov 28.

Reference Type: RESULT

PMID: 26627366 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21967362 (View on PubMed)

Other Identifiers

P070704

Identifier Type: -

Identifier Source: org_study_id