A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures

Launched by JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. · Oct 7, 2005

Keywords

ClinConnect Summary

Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as "generalized," originating in both sides of the brain simultaneously, or "partial-onset," starting in one area of the brain. Antiepilepsy medications, such as topiramate, are selected based on seizure type. This is a double-blind, placebo-controlled study in adult patients with difficult to treat partial epilepsy that includes a baseline phase and a treatment phase. During the baseline phase (8 weeks duration), patients recei...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • History of simple or complex partial epilepsy that has been documented or witnessed
• • an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy
• • during an 8-week baseline phase, patient must have at least 8 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs) and have no more than one seizure-free interval of up to 3 weeks
• • and no seizure-free interval longer than 3 weeks
• • good physical health.
• Exclusion Criteria:
• • Patients having solely generalized seizures or lacking documentation of partial epilepsy
• • patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy
• • generalized seizures, which are defined by the EEG wave pattern
• • seizures that lack an abnormal pulsation pattern on EEG
• • females who are capable of having children