A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure

Topiramate (RWJ-17021-000) Monotherapy Clinical Trial in Patients With Recently Diagnosed Partial-Onset Seizures

The purposes of this study are (1) to compare the effectiveness of two doses of topiramate and (2) to assess the safety of topiramate alone in the treatment of pediatric and adult patients with recently diagnosed epilepsy characterized by partial-onset seizures.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Topiramate is approved for treating epilepsy in combination with other epilepsy drugs, but not approved for treating epilepsy as sole treatment or in recently diagnosed epilepsy characterized by partial-onset seizures. This is a randomized, double-blind, parallel-group, multicenter trial to investigate the effectiveness and safety of topiramate in pediatric and adult patients with recently diagnosed epilepsy characterized by partial-onset seizures. There are four phases of this trial: Retrospective Baseline, Open-Treatment, Double-Blind, and Long-Term Extension. During the Retrospective Baseline Phase, eligibilities of the potential patients are evaluated. During the Open-Treatment Phase, patients receive 25 milligrams[mg] daily of topiramate to assess their ability to tolerate the medication. During the Double-Blind Phase, patients are randomized to a high or a low dose of topiramate. Patients continue to receive the study medication until one of the following occurs: (1) treatment fails; (2) 4 months have passed since the last patient was randomized; or (3) the patient withdraws from the study. Unless withdrawn from the study, the patient may enter the Long-Term Extension Phase and receive high dose topiramate (maximum of either 1,600mg daily for patients >= 14 years of age, or 24mg/kilogram[kg] for patients < 14 years of age) until the patient withdraws or the study is stopped by the sponsor. The study hypothesis is that topiramate will be effective and well tolerated in treating pediatric and adult patients with recently diagnosed epilepsy characterized by partial-onset seizures. Open-Treatment: topiramate 25mg daily by mouth for 7days. Double-Blind: low dose (50 mg or 25mg daily, depending on body weight) or high dose (500mg or 200mg daily, depending on body weight) for up to 4 months. Long-Term Extension: high dose (1600mg or 24mg/kg daily, maximum) for various duration.

Study Type

Interventional

Enrollment (Actual)

451

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

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body weight between 25 kg and 110 kg (approximately 55-240 lb)
  • Diagnosis of epilepsy characterized by unprovoked partial-onset seizures that were diagnosed within the past three years
  • During the three-month Retrospective Baseline Phase, patients must have had at least one seizure, have had an average of no more than two seizures per month, and have had no more than three seizures in any given month. None of the seizures should occur in a cluster pattern
  • During the three-month Retrospective Baseline Phase, patients must receive either no other standard Anti-Epileptic Drug (AED), or be on one AED
  • Patients currently on one AED must be considered inadequately controlled
  • Must have evidence from computed tomography (CT) or magnetic resonance imaging (MRI) of the absence of an arteriovenous malformation or a progressive lesion such as a tumor.

Exclusion Criteria:

  • Patients who do not have epilepsy, such as patients with pseudoseizures or a treatable cause of seizures
  • Patients with benign rolandic epilepsy
  • Patients with progressive or degenerative disorders
  • Patients with a documented history of generalized tonic-clonic status epilepticus during the three month Retrospective Baseline Phase
  • Patients with a significant history (within the past two years) of medical disease that may impair their reliable participation in the trial or necessitate the use of medication not allowed by this protocol
  • Patients who are unable to take their medication either independently or with assistance.

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
Time to exit during the double blind phase (2 partial onset seizures with or without a secondarily generalized component, a secondarily generalized tonic clonic seizure when none existed prior to this phase, or 1 episode of status epilepticus).

Secondary Outcome Measures

Outcome Measure
Laboratory, vital signs, electrocardiogram data and adverse events reported during the trial.

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.

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

November 1, 1995

Study Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

September 29, 2005

First Submitted That Met QC Criteria

September 29, 2005

First Posted (Estimate)

October 3, 2005

Study Record Updates

Last Update Posted (Estimate)

November 15, 2010

Last Update Submitted That Met QC Criteria

November 12, 2010

Last Verified

November 1, 2010

More Information

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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