Study of three commonly used medicines for patients who have seizures that continue despite initial emergency treatments

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"Is fosphenytoin (Cerebyx or Dilantin), levetiracetam (Keppra), or valproic acid (Depacon or Depakote) best for stopping seizures"
2 to 100 years old
Healthy Volunteers:
seizure, epileptic seizure
Drug study, Phase 3
Most seizures either stop on their own without treatment or stop with initial emergency treatments (medications such as valium). Seizures that persist despite emergency treatments are very dangerous.

The purpose of this study is to find out which of three commonly used medicines is best in patients who have seizures that continue despite initial emergency treatments. The study will find out which is safer and more effective at stopping seizures.
The three medicines are fosphenytoin (also called Cerebyx or Dilantin), levetiracetam (also called Keppra), and valproic acid (also called Depacon or Depakote).

All three medications are approved by the Food and Drug Administration for the prevention of seizures. All three drugs are considered investigational drugs in this study. Levetiracetam and valproic acid have not yet been approved to stop long seizures. Fosphenytoin has been approved by the FDA to stop seizures in adults, but not in children. Doctors have used all three of these medications to safely stop ongoing seizures in adults and children for many years. Doctors are allowed to, and commonly do, use approved medications like this, even if the medicines are not labeled by FDA for that particular use.
This study requires

Treatment for seizure with one of three medications Blood draw Review of medical records until discharge

Who can participate

Inclusion Criteria: Patient witnessed to seize for greater than 5 minute duration prior to treatment with study drug; Patient received adequate dose of benzodiazepines. The last dose of a benzo was administered in the 5-30 minutes prior to study drug administration. The doses may be divided.; continued or recurring seizure in the Emergency Department; Age 2 years or older

Exclusion Criteria:Known pregnancy; Prisoner; Opt-out identification; Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital or other agents defined in the MoP) for this episode of SE; Treatment with sedatives with anticonvulsant properties other than benzodiazepines (propofol, etomidate, ketamine or other agents defined in the MoP); Endotracheal intubation; Acute traumatic brain injury; Known metabolic disorder; Known liver disease; Known severe renal impairment; Known allergy or other known contraindication to FOS, PHT, LEV, or VPA; Hypoglycemia 400 mg/dL; Cardiac arrest and post-anoxic seizures

Study duration and period
Up until discharge from the hospital
Recruitment period
From Sept. 14, 2015
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
  • Benzodiazepine Refractory Status Epilepticus

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