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

An Open Observational Safety Study During Administration of Topamac, as Monotherapy in Epileptic Patients With no Prior Treatment or Unsuccessfully Treated With Other Antiepileptic Drug

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.

Study Overview

• Status: Completed
• Conditions: Seizures, Epileptic
• Intervention / Treatment: Drug: Topiramate

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.

• Study Type: Observational
• Enrollment (Actual): 80

Participation Criteria

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

In this study a total number of 75 patients will be enrolled. Adults and children over 2 years of age who are eligible according to the approved SmPC of topiramate and their seizures are not manageable. Patients with new exposure to an AE treatment for epilepsy or lack of response to the previous treatment. Patients who will agree to sign the written informed consent for the anonymous and confidential use of their medical data with their participation in the study or a relative or a legal authorised representative.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
001	Drug: Topiramate; 75 patients over the age of 2 years old with epilepsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome is efficacy.	Visit 1-5

Secondary Outcome Measures

Outcome Measure	Time Frame
Tolerability	Visit: 1-5
Safety of topiramate monotherapy	Visit: 1-5

Collaborators and Investigators

• Sponsor: Janssen Cilag Pharmaceutica S.A.C.I., Greece

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Study Completion (Actual): February 1, 2007

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: Epilepsy; Seizures; Topiramate; Epilepsy in Children
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Hypoglycemic Agents; Physiological Effects of Drugs; Anticonvulsants; Topiramate
• Other Study ID Numbers: CR002119