A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures

This study has been completed.
Sponsor:
Information provided by:
Janssen Cilag Pharmaceutica S.A.C.I., Greece
ClinicalTrials.gov Identifier:
NCT00297349
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 when used in combination with other medications for seizures in adults and children.


Condition Intervention
Seizures
Epilepsy
Drug: Topiramate

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Open-label Observation Study of Topiramate Administration as Adjuvant Therapy for Focal Epilepsy, Lennox-Gastaut Syndrome Epileptic Seizures and Generalized Tonoclonic Seizures in Adults and Children Aged 2 Years and Older

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluation of the safety of oral topiramate as adjuvant therapy for focal epilepsy, Lennox-Gastaut syndrome epileptic seizures and the generalized tonoclonic seizures in adults and children aged 2 years and older. [ Time Frame: At visit 3-8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety & tolerability evaluation will be performed by reporting AEs & Clinical labs. [ Time Frame: Visits:3-8 ] [ Designated as safety issue: No ]
  • Evaluation of efficacy will be performed with the aid of descriptive statistics. [ Time Frame: Visits:3-8 ] [ Designated as safety issue: No ]
  • Overall assessments of the improvement in the seriousness of seizures will be performed. [ Time Frame: Visits:3-8 ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: November 2003
Study Completion Date: June 2005
Groups/Cohorts Assigned Interventions
001 Drug: Topiramate
Individualization of the treatment should begin from 25 mg for 1 week.

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 an open-label, multi-center observational safety study to collect safety information for oral topiramate given in addition to other medications for 3 types of seizures in adults and in children aged 2 years and older.The 3 seizures types are focal epilepsy, LENNOX-GASTAUT syndrome epileptic seizures and generalized tonic-clonic seizures. Patients whose previous treatment for seizures (one or more antiepileptic drugs) has been judged by their physician to be non-satisfactory will receive 6 months of treatment with topiramate in addition to other antiepileptic medication as prescribed by their physician. Topiramate will be given at low doses initially and gradually increased as necessary to control seizure activity in accordance with Summary of Product Characteristics (SmPC). Patients will be asked to keep a diary of adverse events and seizure activity. Safety evaluations (incidence of adverse events, physical examinations, vital signs and laboratory tests) will be performed throughout the study per investigators usual standard of care. At the end of the study, the treating physician may continue treatment with topiramate and other medication as appropriate. The study hypothesis is that topiramate given in combination with other antiepileptic medications will be effective in achieving and maintaining control of seizure activity and is well-tolerated. 225 adult patients and children aged 2 years or older will be enrolled in the study. Study participants should demonstrate focal epilepsy or epileptic seizures of the LENNOX-GASTAUT syndrome or generalized tonoclonic seizures, who have undergone treatment with one or more antiepileptic drugs and whose treatment should be judged by the investigator as non-satisfactory. 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

225 adult patients and children aged 2 years or older will be enrolled in the study. Study participants should demonstrate focal epilepsy or epileptic seizures of the LENNOX-GASTAUT syndrome or generalized tonoclonic seizures, who should have undergone treatment with one or more antiepileptic drugs and whose treatment should be judged by the inverstigator as non-satisfactory.

Criteria

Inclusion Criteria:

  • Non-premenopausal female patients using a medically acceptable contraceptive method as discussed with their doctor
  • History of the type of seizure during the period prior to inclusion in the study and sufficient medical records to document this. Prior treatment until inclusion in the study with one or more antiepileptic drug treatment judged non-satisfactory by the investigator

Exclusion Criteria:

  • Patients not suffering from epilepsy, whose seizures are due to other causes including disease, exposure to harmful substances, active infection or tumor
  • Patients with a history of generalized status epilepticus (prolonged seizures) within the last three months
  • Patients with progressive brain tumor or other progressive or degenerative disorders
  • Patients with a history (within the previous six months) of mental or emotional disorders requiring shock treatment or major sedation, monoamine oxidase (MAO) inhibitors or medications which affect the central nervous system
  • Patients with any medical or social condition that may affect their ability to take part in study or the safety of the study
  • Patients who cannot take the drug or fill in the diary, either alone or with help. If help is needed, it should be permanently available throughout the study
  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: NCT00297349

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: NCT00297349     History of Changes
Other Study ID Numbers: CR003472
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
Tonic-clonic
Lennox-Gastaut Syndrome
Focal 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 September 30, 2014