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

Completed · Phase 2

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT01118962

Run by

UCB BIOSCIENCES, Inc.

People needed

39

Starts

2010-08-01

Expected to finish

2012-10-01

Last updated by the study team

2018-07-17

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• 603 — Phoenix, Arizona, United States
• 602 — Little Rock, Arkansas, United States
• 628 — Aurora, Colorado, United States
• 613 — Atlanta, Georgia, United States
• 617 — Boise, Idaho, United States
• 614 — Fort Wayne, Indiana, United States
• 605 — Lexington, Kentucky, United States
• 616 — Louisville, Kentucky, United States
• 619 — Scarborough, Maine, United States
• 609 — Bethesda, Maryland, United States
• 615 — Chesterfield, Missouri, United States
• 607 — New York, New York, United States
• 620 — Columbus, Ohio, United States
• 608 — Charleston, South Carolina, United States
• 601 — Nashville, Tennessee, United States
• 612 — Dallas, Texas, United States
• 610 — Norfolk, Virginia, United States
• 623 — Renton, Washington, United States
• 624 — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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