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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonazepam + levetiracetam | Experimental | Clonazepam IV 1 mg+ levetiracetam IV 2500 mg |
|
| Clonazepam + placebo | Active Comparator | Clonazepam IV 1 mg + placebo levetiracetam IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam/Clonazepam | Drug | Association of two anti-epileptic drugs in first line |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Period between the first injection and the clinical stop of the convulsion | up to 15 minutes | |
| Period between the first injection and the presence of signs of awakening | up to three days | |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Carli, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necker Hospital | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26627366 | Result | 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. | |
| 21967362 |
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| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| D002998 | Clonazepam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Clonazepam/Placebo levetiracetam IV | Drug | Association of placebo to an active comparator (clonazepam) |
|
|
| Time of hospitalization |
| up to 15 days |
| Patient's percentage having received the second injection of clonazepam to T5 min | 5 minutes |
| Patient's percentage having received an injection of second anticonvulsivant to T15 min | 15 minutes |
| Patient's percentage presenting signs of awakening to T35 min | 35 minutes |
| Patient's percentage having been intubated for the general anesthesia | 35 minutes |
| 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 |
| Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up | up to 15 days |
| Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital | up to 15 days |
| Frequency of adverse events and their severity | up to 15 days |
| Frequency of respiratory, hemodynamic and cardiac occurence of complications | up to 15 days |
| 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 |
| Derived |
| 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |