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

Status:	Completed
Conditions:	Neurology, Neurology, Epilepsy
Therapuetic Areas:	Neurology, Other
Healthy:	No
Age Range:	16 - 65
Updated:	7/19/2018
Start Date:	August 2010
End Date:	October 2012

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 (NCT01118949) to continue to receive Lacosamide.

Inclusion Criteria:

- 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

Exclusion Criteria:

- Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an
ongoing Serious Adverse Event (SAE)

We found this trial at

sites

Clinical Trial Facility in Dallas Texas

Dallas, Texas 75390

from

Dallas, TX