A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures

April 26, 2010 updated by: Janssen Cilag Pharmaceutica S.A.C.I., Greece

An Open-label Observation Study of Topiramate Administration as Adjuvant Therapy for Focal Epilepsy, Lennox-Gastaut Syndrome Epileptic Seizures and Generalized Tonoclonic Seizures in Adults and Children Aged 2 Years and Older

The purpose of this observational study is to evaluate the safety of topiramate when used in combination with other medications for seizures in adults and children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Topiramate is a medication that is approved for the treatment of seizures. In accordance with International guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety. This is an open-label, multi-center observational safety study to collect safety information for oral topiramate given in addition to other medications for 3 types of seizures in adults and in children aged 2 years and older.The 3 seizures types are focal epilepsy, LENNOX-GASTAUT syndrome epileptic seizures and generalized tonic-clonic seizures. Patients whose previous treatment for seizures (one or more antiepileptic drugs) has been judged by their physician to be non-satisfactory will receive 6 months of treatment with topiramate in addition to other antiepileptic medication as prescribed by their physician. Topiramate will be given at low doses initially and gradually increased as necessary to control seizure activity in accordance with Summary of Product Characteristics (SmPC). Patients will be asked to keep a diary of adverse events and seizure activity. Safety evaluations (incidence of adverse events, physical examinations, vital signs and laboratory tests) will be performed throughout the study per investigators usual standard of care. At the end of the study, the treating physician may continue treatment with topiramate and other medication as appropriate. The study hypothesis is that topiramate given in combination with other antiepileptic medications will be effective in achieving and maintaining control of seizure activity and is well-tolerated. 225 adult patients and children aged 2 years or older will be enrolled in the study. Study participants should demonstrate focal epilepsy or epileptic seizures of the LENNOX-GASTAUT syndrome or generalized tonoclonic seizures, who have undergone treatment with one or more antiepileptic drugs and whose treatment should be judged by the investigator as non-satisfactory. Observational study - No investigational drug administered.

Study Type

Observational

Enrollment (Actual)

153

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

225 adult patients and children aged 2 years or older will be enrolled in the study. Study participants should demonstrate focal epilepsy or epileptic seizures of the LENNOX-GASTAUT syndrome or generalized tonoclonic seizures, who should have undergone treatment with one or more antiepileptic drugs and whose treatment should be judged by the inverstigator as non-satisfactory.

Description

Inclusion Criteria:

  • Non-premenopausal female patients using a medically acceptable contraceptive method as discussed with their doctor
  • History of the type of seizure during the period prior to inclusion in the study and sufficient medical records to document this. Prior treatment until inclusion in the study with one or more antiepileptic drug treatment judged non-satisfactory by the investigator

Exclusion Criteria:

  • Patients not suffering from epilepsy, whose seizures are due to other causes including disease, exposure to harmful substances, active infection or tumor
  • Patients with a history of generalized status epilepticus (prolonged seizures) within the last three months
  • Patients with progressive brain tumor or other progressive or degenerative disorders
  • Patients with a history (within the previous six months) of mental or emotional disorders requiring shock treatment or major sedation, monoamine oxidase (MAO) inhibitors or medications which affect the central nervous system
  • Patients with any medical or social condition that may affect their ability to take part in study or the safety of the study
  • Patients who cannot take the drug or fill in the diary, either alone or with help. If help is needed, it should be permanently available throughout the study

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

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
Drug: Topiramate
Individualization of the treatment should begin from 25 mg for 1 week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the safety of oral topiramate as adjuvant therapy for focal epilepsy, Lennox-Gastaut syndrome epileptic seizures and the generalized tonoclonic seizures in adults and children aged 2 years and older.
Time Frame: At visit 3-8
At visit 3-8

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety & tolerability evaluation will be performed by reporting AEs & Clinical labs.
Time Frame: Visits:3-8
Visits:3-8
Evaluation of efficacy will be performed with the aid of descriptive statistics.
Time Frame: Visits:3-8
Visits:3-8
Overall assessments of the improvement in the seriousness of seizures will be performed.
Time Frame: Visits:3-8
Visits:3-8

Collaborators and Investigators

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

Sponsor

Janssen Cilag Pharmaceutica S.A.C.I., Greece

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, 2003

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

February 24, 2006

First Submitted That Met QC Criteria

February 24, 2006

First Posted (Estimate)

February 28, 2006

Study Record Updates

Last Update Posted (Estimate)

April 27, 2010

Last Update Submitted That Met QC Criteria

April 26, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003472

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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