Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510783
Status:
COMPLETED
Last Update Posted:
2013-12-12
First Post:
2007-07-31
Brief Title:
IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 IVor 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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None