NCT00655486

Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures

A Multicenter, Open-label Extension Trial to Assess the Long-term Safety and Tolerability of Lacosamide as Adjunctive Therapy in Subjects With Partial-onset Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to allow eligible subjects from the parent study, SP925 \[NCT00655551\] to continue lacosamide and to obtain additional long-term safety data

Detailed description

A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study \[NCT00655551\] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).

Conditions

• Partial Epilepsies
• Partial Onset Seizures

Interventions

Type	Name	Description
DRUG	lacosamide	Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-04-10
• Last updated: 2018-07-17
• Results posted: 2011-07-15

Locations

7 sites across 1 country: United States