First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine seizure control and tolerability of Topiramate after either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Taiwan Ltd
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Must be diagnosed with seizure disorder

• Have been receiving concomitant therapy with one antiepileptic drug (AED), at stable dose prior to trial entry

• Must be dissatisfied with the current treatment

Exclusion Criteria:

• Have treatable cause of seizures (eg, metabolic disturbance, toxic exposure, an active infection, or neoplasm)

• Have grade IV astrocytomas, eg, Glioblastoma multiforme (GBM) or metastases with progression

• Have seizures occurring only in clustered patterns defined as numerous seizures occurring in less than 30 min

• Have had history (within past six months) of a psychiatric or mood disorder requiring electroconvulsive therapy, major tranquilizers, or monoamine oxidase inhibitors

• Have had schizophrenic or history of exhibiting psychotic symptomatology

• Inability to take medication or maintain a seizure calendar, independently or with assistance