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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01150331
First received: April 23, 2010
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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) [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 203
Study Start Date: July 2009
Study Completion Date: October 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150331

Locations
France
Necker Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Pierre Carli, MD, PhD AP-HP
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01150331     History of Changes
Other Study ID Numbers: P070704
Study First Received: April 23, 2010
Last Updated: June 20, 2014
Health Authority: France: Ministry of Health

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:
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Anticonvulsants
Clonazepam
Piracetam
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nootropic Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 23, 2014