CompletedPhase 3

An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures

403 participantsStarted 2009-01

Plain-language summary

The purpose of this study is to obtain long-term safety and tolerability information on carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy. Seizure counts will be obtained to measure the rate of seizures for each patient during the study.

Who can participate

Age range16 Years

SexALL

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Inclusion Criteria: * Must have completed the 14-week double-blind treatment phase of study CARISEPY3013 * must be willing/able to follow the restrictions and prohibitions of the protocol * must be able to complete the patient diaries correctly (patients or legally acceptable representatives) * must sign an informed consent form indicating agreement to participate in the study (patients or legally acceptable representatives) * adolescents capable of understanding the nature of the study must provide assent to participate in the study Exclusion Criteria: * Patients who have not completed the 14-week double-blind treatment phase of study CARISEPY3013.

What they're measuring

Safety will be evaluated by the monitoring of the frequency, severity, and timing of adverse events, clinical laboratory test results, 12-lead electrocardiogram (ECG) recordings, vital signs measurements, physical and neurologic examinations

Timeframe: after a stable dose of Carisbamate is achieved, study visits to assess safety will be every three months for the duration of the subject's participation; subjects will also maintain a seizure count diary

Trial details

NCT IDNCT00744731

SponsorSK Life Science, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-08