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Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01118962
First received: May 5, 2010
Last updated: October 26, 2012
Last verified: October 2012
History of Changes

May 5, 2010
October 26, 2012
August 2010
October 2012   (final data collection date for primary outcome measure)
  • 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  • Number of participants withdrawn from the study due to treatment-emergent adverse events (TEAEs) during the 56-week treatment phase [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01118962 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
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

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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
Drug: Lacosamide
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®
Experimental: Lacosamide
Intervention: Drug: Lacosamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject completed the SP0961 study
  • Subject is expected to benefit from participation in an open-label extension study with lacosamide, in the opinion of the investigator

Exclusion Criteria:

  • Subject meets the withdrawal criteria for SP0961 or is experiencing an ongoing serious adverse event (SAE)
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01118962
SP0962
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP