CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 158 enrolled
Drug / intervention
Keppra +2 moredrug
Likely dose
Keppra 100mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00510783
NCT00510783Phase 4Completed

IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures

Emory University·interventional·Posted Aug 2, 2007·Updated Dec 12, 2013

In Brief

A Phase 4 clinical trial evaluating Keppra, Fosphenytoin, and 1 other intervention for Tonic-clonic Seizure. Completed, enrolled 158 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsUCB Pharma

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2, 2007
Enrollment StartJul 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.9 years ago

Interventions

Keppradrug

The patient will receive 1 gram of Keppra added to 100ml diluent and will be infused over 15 minutes.

Fosphenytoindrug

IV load will be dependant on dilantin level. If no dilantin is detected in the patient, the patient will receive 1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals.

Dilantindrug

IV load will be dependant on dilantin level. If no dilantin is detected in the patient, the patient will receive 1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals.