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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00297323
Recruitment Status : Completed
First Posted : February 28, 2006
Last Update Posted : April 27, 2010
Information provided by:
Janssen Cilag Pharmaceutica S.A.C.I., Greece

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.

Condition or disease Intervention/treatment
Seizures, Epileptic 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
Actual Enrollment : 80 participants
Time Perspective: Prospective
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
Study Start Date : June 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Topiramate
U.S. FDA Resources

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

Primary Outcome Measures :
  1. The primary outcome is efficacy. [ Time Frame: Visit 1-5 ]

Secondary Outcome Measures :
  1. Tolerability [ Time Frame: Visit: 1-5 ]
  2. Safety of topiramate monotherapy [ Time Frame: Visit: 1-5 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00297323

Sponsors and Collaborators
Janssen Cilag Pharmaceutica S.A.C.I., Greece
Study Director: Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial Janssen-Cilag Pharmaceutica S.A.C.I.

Responsible Party: Medical Affairs Director, Janssen Cilag Pharmaceutica S.A.C.I., Greece Identifier: NCT00297323     History of Changes
Other Study ID Numbers: CR002119
First Posted: February 28, 2006    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: April 2010

Keywords provided by Janssen Cilag Pharmaceutica S.A.C.I., Greece:
Epilepsy in Children

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents