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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01150331
First received: April 23, 2010
Last updated: August 2, 2013
Last verified: August 2013

April 23, 2010
August 2, 2013
July 2009
May 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01150331 on ClinicalTrials.gov Archive Site
  • Period between the first injection and the clinical stop of the convulsion [ Time Frame: up to 15 minutes ] [ Designated as safety issue: Yes ]
  • Period between the first injection and the presence of signs of awakening [ Time Frame: up to three days ] [ Designated as safety issue: Yes ]
  • Time of hospitalization [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
  • Patient's percentage having received the second injection of clonazepam to T5 min [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]
  • Patient's percentage having received an injection of second anticonvulsivant to T15 min [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
  • Patient's percentage presenting signs of awakening to T35 min [ Time Frame: 35 minutes ] [ Designated as safety issue: Yes ]
  • Patient's percentage having been intubated for the general anesthesia [ Time Frame: 35 minutes ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
  • Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
  • Frequency of adverse events and their severity [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
  • Frequency of respiratory, hemodynamic and cardiac occurence of complications [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Period between the first injection and the clinical stop of the convulsion [ Time Frame: up to 15 minutes ] [ Designated as safety issue: Yes ]
  • Period between the first injection and the presence of signs of awakening [ Time Frame: up to three days ] [ Designated as safety issue: Yes ]
  • Time of hospitalization [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
  • Patient's percentage having received the second injection of clonazepam to T5 min [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]
  • Patient's percentage having received an injection of second anticonvulsivant to T15 min [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
  • Patient's percentage presenting signs of awakening to T35 min [ Time Frame: 35 minutes ] [ Designated as safety issue: Yes ]
  • Patient's percentage having been intubated for the general anesthesia [ Time Frame: 35 minutes ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
  • Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
  • Frequency of adverse events and their severity [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
  • Frequency of respiratory, hemodynamic and cardiac occurence of complications [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
  • Analysis of the main criteria of efficiency by sous groups according to the etiology of the generalised tonic-clonic status epileptics and according to this duration during the therapeutic clinical care [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus
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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Status; Epilepticus, Tonic-clonic
  • Drug: Levetiracetam/Clonazepam
    Association of two anti-epileptic drugs in first line
    Other Name: Association of two anti-epileptic drugs in first line
  • Drug: Clonazepam/Placebo levetiracetam IV
    Association of placebo to an active comparator (clonazepam)
    Other Name: Association of placebo to an active comparator (clonazepam)
  • Experimental: Clonazepam + levetiracetam
    Clonazepam IV 1 mg+ levetiracetam IV 2500 mg
    Intervention: Drug: Levetiracetam/Clonazepam
  • Active Comparator: Clonazepam + placebo
    Clonazepam IV 1 mg + placebo levetiracetam IV
    Intervention: Drug: Clonazepam/Placebo levetiracetam IV
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
191
September 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01150331
P070704
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Study Chair: Pierre Carli, MD, PhD AP-HP
Assistance Publique - Hôpitaux de Paris
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP