Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
The purpose is to obtain data on the safety and seizure frequency associated with long-term oral lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized epilepsy. Additionally, to allow subjects who have completed SP0961 to continue to receive lacosamide.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Long-Term Oral Lacosamide for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy|
- Number of participants with treatment-emergent adverse events (TEAEs) during the 56-week treatment phase [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
- Number of participants withdrawn from the study due to treatment-emergent adverse events (TEAEs) during the 56-week treatment phase [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Lacosamide is supplied as 50 mg and 100 mg tablets. The starting lacosamide dose will be the same dose reached by a subject at the end of SP0961. At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100mg/day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/day per week up to a maximum of 800 mg/day. Lacosamide will be administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase is followed by a 5-week End-of-Study Phase, lasting up to 5 weeks, during which subjects will be tapered off lacosamide at a recommended decrease rate of 200 mg/day per week.
Other Name: Vimpat®
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|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|