- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00210782
A Comparison of the Effectiveness and Safety of Topiramate and Phenytoin in Patients With New Onset Epilepsy Requiring Rapid Initiation of Antiepileptic Drug Treatment
June 8, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-blind Trial Comparing the Efficacy, Tolerability and Safety of Monotherapy Topiramate Versus Phenytoin in Subjects With Seizures Indicative of New Onset Epilepsy
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
262
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Seizures indicative of new-onset epilepsy (or epilepsy relapse) of untreated epilepsy
- at least one but not more than 20 unprovoked seizures within past 3 months
- weighing more than 110 pounds
- considered to be a good candidate for rapid initiation of anti-seizure medication
- able to swallow a tablet whole (without crushing it).
Exclusion Criteria:
- Not having taken anti-seizure medications within the past 30 days
- no provoking factors for seizures (presence of alcohol withdrawal, drug intoxication, acute meningitis or encephalitis, acute head injury or stroke, acute hypoxic/ischemic encephalopathy, or brain tumor)
- no presence of active liver disease or serious kidney disease
- not pregnant or breast-feeding
- not using birth control.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications.
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Secondary Outcome Measures
Outcome Measure |
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Effect of sex, age, baseline weight, baseline seizure type, and duration since first diagnosis of epilepsy on the time to seizure.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
June 10, 2011
Last Update Submitted That Met QC Criteria
June 8, 2011
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epilepsy
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Anticonvulsants
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Topiramate
- Phenytoin
Other Study ID Numbers
- CR004663
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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