An Observational Study of the Safety of Topiramate in Adults and Children With Epilepsy

NCT ID: NCT00297323

Last Updated: 2010-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2007-02-28

Brief Summary

The purpose of this observational study is to evaluate the safety of topiramate in adults and children with epilepsy (or seizures) who have not received or have not responded to treatment with previous antiepileptic medication.

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 a multi-center, open-label observational safety study to collect information regarding the dosage, tolerability and effectiveness of topiramate in adults and children with epilepsy (or seizures). Patients who have not received previous treatment for epilepsy or for whom previous treatment was ineffective or intolerable will receive 6 months of treatment with topiramate. Topiramate will be given at low doses initially and gradually increased as needed for each patient to control seizure activity. Safety evaluations (incidence of adverse events and laboratory tests) and assessment of patient health status will be performed throughout the study. Effectiveness will be evaluated by recording the frequency of seizures occurring during the study. Patient and physician satisfaction with topiramate treatment will also be recorded. At the end of the study, the treating physician may continue treatment with topiramate in responding patients as appropriate. The study hypothesis is that topiramate will be effective in achieving and maintaining control of seizure activity and is well-tolerated. Observational study - No investigational drug administered.

Conditions

Seizures, Epileptic

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

001

Topiramate

Intervention Type: DRUG

75 patients over the age of 2 years old with epilepsy.

Interventions

Topiramate

75 patients over the age of 2 years old with epilepsy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who have not received previous treatment with antiepileptic medications or patients who did not respond to previous treatment with antiepileptic medications, defined as a lack of effectiveness of the medication(s), or the inability to take the medication(s) due to adverse effects

Exclusion Criteria

• Patients not suffering from epilepsy, whose seizures are due to other causes including disease, exposure to harmful substances, active infection or tumor and are manageable
• Patients with a hypersensitivity to topiramate or to some of its components
• Patients who should not take Topiramate for reasons listed in its approved Summary of Product Characteristics (printed information about a medication that describes its actions, side effects and intended patients)
• Patients who are uncooperative or for whom obtaining compliance with study visit schedules and procedures and information required by the study would be difficult

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

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

Principal Investigators

Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Pharmaceutica S.A.C.I.

Other Identifiers

CR002119

Identifier Type: -

Identifier Source: org_study_id