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

NCT00297349 | Completed

• 1 other identifier: CR003472
• Study Type: observational
• Target: 153
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Seizures; Epilepsy

Keywords

Seizures; Epilepsy; Tonic-clonic; Lennox-Gastaut Syndrome; Focal Epilepsy; Topiramate; Epilepsy in Children

Outcome Measures

Primary Outcomes (1)

• 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.

  At visit 3-8

Secondary Outcomes (3)

• Safety & tolerability evaluation will be performed by reporting AEs & Clinical labs.

  Visits:3-8

• Evaluation of efficacy will be performed with the aid of descriptive statistics.

  Visits:3-8

• Overall assessments of the improvement in the seriousness of seizures will be performed.

  Visits:3-8

Study Arms (1)

001

Drug: Topiramate

Interventions

Topiramate DRUG

Individualization of the treatment should begin from 25 mg for 1 week.

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

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.

You may qualify if:

• Non-premenopausal female patients using a medically acceptable contraceptive method as discussed with their doctor

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
• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Seizures; Epilepsy; Lennox Gastaut Syndrome; Epilepsies, Partial

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Epileptic Syndromes; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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: November 1, 2003
• Study Completion: June 1, 2005
• Last Updated: April 27, 2010

Record last verified: 2010-04