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

NCT00297323 | Completed

• 1 other identifier: CR002119
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Seizures, Epileptic

Keywords

Seizures; Epilepsy; Topiramate; Epilepsy in Children

Outcome Measures

Primary Outcomes (1)

• The primary outcome is efficacy.

  Visit 1-5

Secondary Outcomes (2)

• Tolerability

  Visit: 1-5

• Safety of topiramate monotherapy

  Visit: 1-5

Study Arms (1)

001

Drug: Topiramate

Interventions

Topiramate DRUG

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

001

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Seizures; Epilepsy

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 28, 2006
• Study Start: June 1, 2005
• Study Completion: February 1, 2007
• Last Updated: April 27, 2010

Record last verified: 2010-04