A Comparison of the Effectiveness and Safety of Topiramate and Phenytoin in Patients With New Onset Epilepsy Requiring Rapid Initiation of Antiepileptic Drug Treatment
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness and safety of two treatment
      regimens, topiramate as compared to phenytoin, in preventing seizures in patients with
      new-onset epilepsy who require rapid initiation of antiepileptic drug therapy. Reasons for
      requiring rapid initiation of treatment, rather than slowly increasing an antiepileptic drug
      to an effective dose, may include severe or frequent seizures, or high risk to the patient of
      recurrent seizures.
    

Detailed description: 
      In this study, patients who have recently been diagnosed with epilepsy and who require rapid
      initiation of treatment will be randomized to receive either phenytoin or topiramate.
      Patients have an equal chance of receiving either medication. Phenytoin and topiramate have
      been approved by the FDA for treatment of epilepsy. The first phase of this study (lasting 28
      days) is double-blind, meaning that neither the patient or the physician know which
      medication the patient is receiving. Phenytoin will be used according to the dosing
      recommendation in the package insert. Patients randomized into the phenytoin arm of this
      study, will receive a dose on day 1 of 1000mg phenytoin (given in 3 divided doses), an
      initiation dose recommended in the product labeling. This will be followed by 300mg of
      phenytoin on each subsequent day. Patients randomized into the topiramate arm of this study
      will receive 100mg of topiramate on day 1 and then continue to receive 100mg on each
      subsequent day. This is a relatively rapid initiation schedule of topiramate, but it is
      anticipated that it will be well tolerated and represents an appropriate regimen for
      comparison to patients in the phenytoin arm of the study. Patients will be carefully
      monitored for primary generalized tonic clonic seizures or complex partial onset seizures
      (two distinct epileptic seizure types) during the 28-day double-blind evaluation period of
      the trial. If a patient experiences a seizure during this 28 day period, they will either be
      taken out of the study, or be offered the option to receive a higher dose of topiramate in an
      open-label fashion. Open-label means that the patient and the physician will know what
      medication and what dose of the medication the patient is taking. All patients who do not
      experience a seizure during the 28 day period will be offered to receive open-label
      topiramate for an additional 12 weeks. The study hypothesis is that the proportion of
      patients who do not have a seizure within the 28 day double blind phase of the study will not
      differ between the 2 treatment groups. Topiramate 100 milligrams a day by mouth for 4 weeks;
      phenytoin 1000 milligrams to start, decreased to 300 milligrams a day by mouth for 4 weeks.
    

Intervention name(s): topiramate, phenytoin
Intervention type(s): Drug
Intervention MeSH terms: Topiramate; Phenytoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: epilepsy; seizures; epileptic seizures; complex partial seizures; generalized tonic-clonic seizures