Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
- Registration Number
- NCT01118962
- Lead Sponsor
- UCB BIOSCIENCES, Inc.
- Brief Summary
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 (NCT01118949) to continue to receive Lacosamide.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- Subject completed the SP0961 (NCT01118949) study
- Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator
- Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lacosamide Lacosamide Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) From Visit 1 to the end of study (Approximately 61 weeks) Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) From Visit 1 to the end of study (Approximately 61 weeks)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
609
🇺🇸Bethesda, Maryland, United States
601
🇺🇸Nashville, Tennessee, United States
605
🇺🇸Lexington, Kentucky, United States
603
🇺🇸Phoenix, Arizona, United States
628
🇺🇸Aurora, Colorado, United States
607
🇺🇸New York, New York, United States
616
🇺🇸Louisville, Kentucky, United States
623
🇺🇸Renton, Washington, United States
624
🇺🇸Madison, Wisconsin, United States
610
🇺🇸Norfolk, Virginia, United States
613
🇺🇸Atlanta, Georgia, United States
617
🇺🇸Boise, Idaho, United States
614
🇺🇸Fort Wayne, Indiana, United States
619
🇺🇸Scarborough, Maine, United States
612
🇺🇸Dallas, Texas, United States
615
🇺🇸Chesterfield, Missouri, United States
620
🇺🇸Columbus, Ohio, United States
602
🇺🇸Little Rock, Arkansas, United States
608
🇺🇸Charleston, South Carolina, United States