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

Seizures, Epileptic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297323
• Other study ID #: CR002119
• Status: Completed
• Phase: N/A
• First received: February 24, 2006
• Last updated: April 26, 2010
• Start date: June 2005
• Est. completion date: February 2007

Study information

• Verified date: April 2010
• Source: Janssen Cilag Pharmaceutica S.A.C.I., Greece
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Hellenic Republic Ministry Of Health And Welfare National Organization For Medicines
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy
• Seizures, Epileptic

Intervention

Drug:
• Topiramate
75 patients over the age of 2 years old with epilepsy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Cilag Pharmaceutica S.A.C.I., Greece

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is efficacy.		Visit 1-5	Yes
Secondary	Tolerability		Visit: 1-5	No
Secondary	Safety of topiramate monotherapy		Visit: 1-5	Yes