An Observational Study of the Safety of Topiramate in Adults and Children With Epilepsy
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Purpose
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 | Intervention |
|---|---|
|
Seizures, Epileptic |
Drug: Topiramate |
| Study Type: | Observational |
| Study Design: | 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 |
- The primary outcome is efficacy. [ Time Frame: Visit 1-5 ] [ Designated as safety issue: Yes ]
- Tolerability [ Time Frame: Visit: 1-5 ] [ Designated as safety issue: No ]
- Safety of topiramate monotherapy [ Time Frame: Visit: 1-5 ] [ Designated as safety issue: Yes ]
| Enrollment: | 80 |
| Study Start Date: | June 2005 |
| Study Completion Date: | February 2007 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 001 |
Drug: Topiramate
75 patients over the age of 2 years old with epilepsy.
|
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.
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Medical Affairs Director, Janssen Cilag Pharmaceutica S.A.C.I., Greece |
| ClinicalTrials.gov Identifier: | NCT00297323 History of Changes |
| Other Study ID Numbers: | CR002119 |
| Study First Received: | February 24, 2006 |
| Last Updated: | April 26, 2010 |
| Health Authority: | Greece: Hellenic Republic Ministry Of Health And Welfare National Organization For Medicines |
Keywords provided by Janssen Cilag Pharmaceutica S.A.C.I., Greece:
|
Seizures Epilepsy Topiramate Epilepsy in Children |
Additional relevant MeSH terms:
|
Epilepsy Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Topiramate |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |
ClinicalTrials.gov processed this record on May 19, 2013