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

Primary Purpose

Status; Epilepticus, Tonic-clonic

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Levetiracetam/Clonazepam
Clonazepam/Placebo levetiracetam IV
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status; Epilepticus, Tonic-clonic focused on measuring status epilepticus, generalised convulsive status epilepticus, first line treatments, double-blind randomized controlled trial, prehospital treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Necker Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clonazepam + levetiracetam

Clonazepam + placebo

Arm Description

Clonazepam IV 1 mg+ levetiracetam IV 2500 mg

Clonazepam IV 1 mg + placebo levetiracetam IV

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2010
Last Updated
June 20, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01150331
Brief Title
Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus
Acronym
SAMU-KEPPRA
Official Title
Efficiency of Levetiracetam Intravenous in Association With Clonazepam Versus Clonazepam Alone in Prehospital Care of Generalised Tonicoclonic Status Epilepticus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status; Epilepticus, Tonic-clonic
Keywords
status epilepticus, generalised convulsive status epilepticus, first line treatments, double-blind randomized controlled trial, prehospital treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clonazepam + levetiracetam
Arm Type
Experimental
Arm Description
Clonazepam IV 1 mg+ levetiracetam IV 2500 mg
Arm Title
Clonazepam + placebo
Arm Type
Active Comparator
Arm Description
Clonazepam IV 1 mg + placebo levetiracetam IV
Intervention Type
Drug
Intervention Name(s)
Levetiracetam/Clonazepam
Other Intervention Name(s)
Association of two anti-epileptic drugs in first line
Intervention Description
Association of two anti-epileptic drugs in first line
Intervention Type
Drug
Intervention Name(s)
Clonazepam/Placebo levetiracetam IV
Other Intervention Name(s)
Association of placebo to an active comparator (clonazepam)
Intervention Description
Association of placebo to an active comparator (clonazepam)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Period between the first injection and the clinical stop of the convulsion
Time Frame
up to 15 minutes
Title
Period between the first injection and the presence of signs of awakening
Time Frame
up to three days
Title
Time of hospitalization
Time Frame
up to 15 days
Title
Patient's percentage having received the second injection of clonazepam to T5 min
Time Frame
5 minutes
Title
Patient's percentage having received an injection of second anticonvulsivant to T15 min
Time Frame
15 minutes
Title
Patient's percentage presenting signs of awakening to T35 min
Time Frame
35 minutes
Title
Patient's percentage having been intubated for the general anesthesia
Time Frame
35 minutes
Title
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
Title
Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up
Time Frame
up to 15 days
Title
Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital
Time Frame
up to 15 days
Title
Frequency of adverse events and their severity
Time Frame
up to 15 days
Title
Frequency of respiratory, hemodynamic and cardiac occurence of complications
Time Frame
up to 15 days
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Carli, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Necker Hospital
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21967362
Citation
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.
Results Reference
derived

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Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus

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