Clinical Trial: Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Idiopathi
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 Summary:
Sponsor: UCB BIOSCIENCES, Inc.
Current Primary Outcome:
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) [ Time Frame: 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- Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) [ Time Frame: From Visit 1 to the end of study (Approximately 61 weeks) ]
Original Primary Outcome:
- Number of participants with treatment-emergent adverse events (TEAEs) during the 56-week treatment phase [ Time Frame: 56 weeks ]
- Number of participants withdrawn from the study due to treatment-emergent adverse events (TEAEs) during the 56-week treatment phase [ Time Frame: 56 weeks ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: UCB Pharma
Dates:
Date Received: May 5, 2010
Date Started: August 2010
Date Completion:
Last Updated: March 23, 2015
Last Verified: March 2015
