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

Completed

• Conditions: Seizures; Epilepsy
• Interventions: Drug: Topiramate

• Registration Number: NCT00297349
• Lead Sponsor: Janssen Cilag Pharmaceutica S.A.C.I., Greece

Brief Summary

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.

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 Timeline

• Study Start: 2003-11
• Study Completion: 2005-06
• Study First Submitted: 2006-02-24
• Study First Submitted QC: 2006-02-24
• Study First Posted: 2006-02-28
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-26
• Last Update Posted: 2010-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	Topiramate	-

Primary Outcome Measures

Name	Time	Method
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.	At visit 3-8

Secondary Outcome Measures

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