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

NCT00510783 | Completed Phase 4 Results DMC

• 1 other identifier: IRB00002266
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Tonic-clonic Seizure

Keywords

tonic-clonic seizure; emergency department; IV levetiracetam; Keppra; seizures; phenytoin; Dilantin; Grand Mal seizure

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced a Recurrent Seizure After Treatment.

  Recurrent seizure is defined as a seizure within 24 hours of treatment in the Emergency Department.

  24 hours

Study Arms (2)

Phenytoin/Fosphenytoin

ACTIVE COMPARATOR

Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).

Drug: Fosphenytoin; Drug: Dilantin

Levetiracetam

ACTIVE COMPARATOR

Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).

Drug: Keppra

Interventions

Keppra DRUG

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

Also known as: levetiracetam

Levetiracetam

Fosphenytoin DRUG

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.

Also known as: Cerebyx

Phenytoin/Fosphenytoin

Dilantin DRUG

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.

Also known as: phenytoin

Phenytoin/Fosphenytoin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• UCB Pharma: collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Seizures; Emergencies; Epilepsy, Tonic-Clonic

Interventions

Levetiracetam; fosphenytoin; Phenytoin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydantoins; Imidazolidines; Imidazoles; Azoles

Limitations and Caveats

Several patients were lost to follow-up.

Results Point of Contact

• Title: Brittney Copeland
• Organization: Emory

bcopel3@emory.edu

404-616-0301

Study Officials

• Debra Houry, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 2, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 12, 2013
• Results First Posted: August 5, 2013

Record last verified: 2013-11

Locations

US (1)