A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures

June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Double-Blind Parallel Comparison of Topiramate 400 mg Twice Daily to Placebo in Patients With Refractory Partial Epilepsy

The purpose of this study is to evaluate the efficacy and safety of topiramate as add-on therapy in epilepsy patients with difficult to treat, partial-onset seizures who are taking one or two standard anti-epileptic drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as "generalized," originating in both sides of the brain simultaneously, or "partial-onset," starting in one area of the brain. Antiepilepsy medications, such as topiramate, are selected based on seizure type. This is a double-blind, placebo-controlled study in adult patients with difficult to treat partial epilepsy that includes a baseline phase and a treatment phase. During the baseline phase (8 weeks duration), patients receive their one or two standard antiepileptic drugs (AEDs), such as phenytoin, carbamazepine, phenobarbital, primidone, or valproic acid. Patients who continue to have seizures during treatment with standard AEDs proceed into the double-blind treatment phase. Patients then receive topiramate or placebo at a dosage of 100-milligrams (mg) once daily, increasing gradually over 5 weeks to 4 tablets twice daily (800 mg/day) or maximum tolerated dose, and maintained on that dose for 8 weeks (13 weeks is the total duration of the double-blind phase), while continuing on their standard AED regimen. Assessments of effectiveness include the percent reduction in the average monthly seizure rate, percent of patients responding to treatment (having equal to or greater than 50% reduction in seizure rate), and the patient's and investigator's global assessments of medication at end of study. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, urinalysis), neurologic examinations, and vital sign measurements (blood pressure, pulse, temperature) weekly during the treatment phase. The study hypothesis is that topiramate, taken as add-on therapy to treatment with AEDs, will significantly reduce seizure frequency, compared with placebo, in patients with refractory partial epilepsy: that is, in patients who continue to have seizures despite treatment with a first-line AEDs. In addition, it is hypothesized that topiramate will be well tolerated. Topiramate, 100 mg oral tablets, or matching placebo tablets. Dosage begins at 100 mg once daily and increases gradually over 5 weeks to 4 tablets twice daily (800 mg/day, maximum) or maximum tolerated dose for an additional 8 weeks. Doses may be increased or decreased at investigator's discretion.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of simple or complex partial epilepsy that has been documented or witnessed
  • an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy
  • during an 8-week baseline phase, patient must have at least 8 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs) and have no more than one seizure-free interval of up to 3 weeks
  • and no seizure-free interval longer than 3 weeks
  • good physical health.

Exclusion Criteria:

  • Patients having solely generalized seizures or lacking documentation of partial epilepsy
  • patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy
  • generalized seizures, which are defined by the EEG wave pattern
  • seizures that lack an abnormal pulsation pattern on EEG
  • females who are capable of having children

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
Percent reduction in the average monthly seizure rate from baseline to end of treatment

Secondary Outcome Measures

Outcome Measure
Percent of patients responding to treatment; patient's and investigator's global assessments at end of study rate; reduction in generalized seizureincidence of adverse events throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

General Publications

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

May 1, 1989

Study Completion (Actual)

February 1, 1992

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005569

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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