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

This study has been completed.
Sponsor:
Information provided by:
Janssen Cilag Pharmaceutica S.A.C.I., Greece
ClinicalTrials.gov Identifier:
NCT00297323
First received: February 24, 2006
Last updated: April 26, 2010
Last verified: April 2010
  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

Resource links provided by NLM:


Further study details as provided by Janssen Cilag Pharmaceutica S.A.C.I., Greece:

Primary Outcome Measures:
  • The primary outcome is efficacy. [ Time Frame: Visit 1-5 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297323

Sponsors and Collaborators
Janssen Cilag Pharmaceutica S.A.C.I., Greece
Investigators
Study Director: Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial Janssen-Cilag Pharmaceutica S.A.C.I.
  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
Anti-Obesity Agents
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014