Tonic-clonic Seizure Clinical Trial
Official title:
IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures
This study is looking at three seizure medicines. Patients with seizures are usually treated with phenytoin (Dilantin) or Fosphenytoin. These medicines can be given intravenously (IV)or by mouth. Another seizure medicine, levetiracetam (Keppra) can now be given this way also. This study will compare IV phenytoin (Dilantin) and IV fosphenytoin to levetiracetam (Keppra) in patients who have had a recent seizure. Only patients with a history of seizures can be involved. The patient must present to the emergency department within 4 hours of a seizure. The purpose of this study is to compare these three drugs, phenytoin (Dilantin), fosphenytoin, and levetiracetam (Keppra). The investigators are looking to see if these drugs can prevent another seizure in the next 24 hours. We are also looking for any possible side effects.
More than one in every one hundred patients presenting to the emergency department for care
do so for seizures. More than half of these patients will require medications, often
intravenously (IV), while in the emergency department. For many years the standard treatment
has been phenytoin. However, there are many known contraindications to the use of this drug.
These include known hypersensitivity, cardiac arrhythmias, cardiac disease, impaired liver
or kidney function, diabetes mellitus, older age, thyroid disease, pregnancy, and alcohol
use. A recent review of patients with seizure disorder at Emory Crawford Long and Emory
University hospitals suggested that a significant percentage of those who were taking
phenytoin actually had one or more of these contraindications. Additionally, the IV form of
phenytoin has known, severe adverse effects including cardiovascular collapse, life
threatening cardiac arrhythmias, and severe hypotension. There is another form of Phenytoin,
called Fosphenytoin, that while safer in some respects still has similar concerns associated
with its administration.
Levetiracetam (Keppra) has been available as an oral drug in the United States since 2000
and has a well established safety record when used as an add-on drug for patients with
partial onset seizures. A double-blinded randomized study has shown that levetiracetam is
also effective for primary generalized seizures as well.
The IV form of levetiracetam has recently been approved by the FDA for use. The only known
contraindications other than known hypersensitivity include impaired renal function,
psychiatric disorder, older age, and pregnancy. IV levetiracetam is not known to cause any
of the acute, catastrophic events seen occasionally with phenytoin.
The investigators would therefore like to compare IV phenytoin and fosphenytoin to IV
levetiracetam in preventing early recurrent seizures. Patients with known seizure disorders
would be randomly assigned to one of two groups and therefore receive either IV fosphenytoin
or IV levetiracetam. After an observation period, seizure free patients would be discharged
and 24 hour phone follow up conducted to assess for the effectiveness of these anti-seizure
medications as well as for any adverse reactions.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment