Phase 4
N=158
IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures
Tonic-clonic Seizure
Bottom Line
View on ClinicalTrials.gov: NCT00510783 ↗Enrolled (actual)
158
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Number of Participants Who Experienced a Recurrent Seizure After Treatment. — 2; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Keppra (Drug); Fosphenytoin (Drug); Dilantin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced a Recurrent Seizure After Treatment. |
2; 3 | — |
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 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.
Eligibility 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 to the Emergency Department. The most likely expected causes of a seizure are noncompliance to existing antiepileptic drug 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
Data sourced from ClinicalTrials.gov (NCT00510783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.