IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures
Information source: Emory University
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tonic-Clonic Seizure (Primary or Secondarily Generalized); Grand Mal Seizure
Intervention: Keppra (Drug); Dilantin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Emory University Official(s) and/or principal investigator(s):
Matt Graber, MD, Principal Investigator, Affiliation: Emory University
Overall contact:
Brittney L Copeland, Phone: 404.616.0301, Email: brittney.copeland@emory.edu
Summary
This study is looking at three seizure medicines. Patients with seizures are usually treated
with phenytoin (Dilantin)or Fosphenytoin. These medicines can be given by 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 fro any possible side effects.
Clinical Details
Official title: IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To determine if IV levetiracetam is safe and effective in preventing early recurrent seizures for 24 hours compared to phenytoin and fosphenytoin in patients who present to the ED within 4 hours of a tonic-clonic seizure.
Detailed description:
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 US 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.
We would therefore like to compare IV phenytoin and fosphenytion 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- age 18 or older
- patient presenting to Grady Memorial Hospital's Emergency Department after having a
tonic-clonic seizure (primary or secondarily generalized)within the last 4 hours
Cause of seizure for inclusion: reason for seizure is often undetermined at time of
presentation of ED. The most likely expected causes of a seizure are noncompliance to
existing AED regimen, refractory epilepsy with breakthrough seizure, metabolic aberration,
alcohol withdrawal, or unknown.
Exclusion Criteria:
- non-English speaking
- first time seizure
- seizures other than tonic-clonic seizure (primary or secondarily generalized)
- more than 3 seizures in 24 hours or status epilepticus, pregnant patients by history
or by urine pregnancy testing, serious neurologic insult resulting in seizure but
where seizure is not the primary reason for admission (e. g. traumatic brain injury
with seizure or hemorrhagic stoke would be excluded)
- contraindication to IV levetiracetam
- received IV phenytoin within 24 hours
- known allergy to phenytoin
- previously enrolled in the study
Locations and Contacts
Brittney L Copeland, Phone: 404.616.0301, Email: brittney.copeland@emory.edu
Grady Memorial Hospital, Atlanta, Georgia 30303, United States; Recruiting
Brittney L Copeland, Phone: 404-616-0301, Email: brittney.copeland@emory.edu
Additional Information
Starting date: July 2007
Ending date: February 2009
Last updated: January 17, 2008
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