SAMUKeppra
Trial question
What is the effect of addition of levetiracetam to clonazepam in patients with generalized convulsive status epilepticus before hospital admission?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 136
136 patients (42 female, 94 male).
Inclusion criteria: adult patients with convulsions lasting > 5 minutes before hospitalization.
Key exclusion criteria: pregnancy; known allergies to clonazepam, levetiracetam, or pyrrolidone; status epilepticus linked to a pathological condition; post-anoxic or subtle status epilepticus.
Interventions
N=68 prehospital levetiracetam (intravenous levetiracetam 2.5 g plus clonazepam 1 mg).
N=68 placebo (matching intravenous placebo plus clonazepam 1 mg).
Primary outcome
Cessation of convulsions within 15 minutes of drug injection
74%
84%
84.0 %
63.0 %
42.0 %
21.0 %
0.0 %
Prehospital
levetiracetam
Placebo
No significant
difference ↔
No significant difference in cessation of convulsions within 15 minutes of drug injection (74% vs. 84%; RR 0.88, 95% CI 0.74 to 1.05).
Secondary outcomes
No significant difference in requirement of a second injection of clonazepam after 5 minutes (42% vs. 43%; RR 0.97, 95% CI 0.65 to 1.44).
No significant difference in requirement of an injection of an antiepileptic drug after 15 minutes (28% vs. 23%; RR 1.23, 95% CI 0.68 to 2.21).
No significant difference in patients with waking signs at 35 minutes (39% vs. 41%; RR 0.95, 95% CI 0.6 to 1.51).
Safety outcomes
No significant differences in prehospital health failures, need for prehospital assistance, death, serious and non-serious adverse events.
Conclusion
In adult patients with convulsions lasting > 5 minutes before hospitalization, prehospital levetiracetam was not superior to placebo with respect to cessation of convulsions within 15 minutes of drug injection.
Reference
Vincent Navarro, Christelle Dagron, Caroline Elie et al. 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.
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