Status; Epilepticus, Tonic-clonic Clinical Trial
— SAMU-KEPPRAOfficial title:
Efficiency of Levetiracetam Intravenous in Association With Clonazepam Versus Clonazepam Alone in Prehospital Care of Generalised Tonicoclonic Status Epilepticus
| Verified date | June 2014 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 203 |
| Est. completion date | October 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Necker Hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes | |
| Secondary | Period between the first injection and the clinical stop of the convulsion | up to 15 minutes | Yes | |
| Secondary | Period between the first injection and the presence of signs of awakening | up to three days | Yes | |
| Secondary | Time of hospitalization | up to 15 days | Yes | |
| Secondary | Patient's percentage having received the second injection of clonazepam to T5 min | 5 minutes | Yes | |
| Secondary | Patient's percentage having received an injection of second anticonvulsivant to T15 min | 15 minutes | Yes | |
| Secondary | Patient's percentage presenting signs of awakening to T35 min | 35 minutes | Yes | |
| Secondary | Patient's percentage having been intubated for the general anesthesia | 35 minutes | Yes | |
| Secondary | 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 | Yes | |
| Secondary | Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up | up to 15 days | Yes | |
| Secondary | Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital | up to 15 days | Yes | |
| Secondary | Frequency of adverse events and their severity | up to 15 days | Yes | |
| Secondary | Frequency of respiratory, hemodynamic and cardiac occurence of complications | up to 15 days | Yes | |
| Secondary | 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 | Yes |