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Sponsored by: |
UCB |
Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00655486 |
The purpose of this trial is to allow eligible subjects from the parent trial to continue lacosamide and to obtain additional long-term safety data.
Condition | Intervention | Phase |
Partial Epilepsies |
Drug: lacosamide |
Phase III |
Genetics Home Reference related topics: | autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy |
MedlinePlus related topics: | Epilepsy Seizures |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Multicenter, Open-Label Extension Trial to Assess the Long-Term Safety and Tolerabiity of Lacosamide as Adjunctive Therapy in Subjects With Partial-Onset Seizures |
Estimated Enrollment: | 100 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Subjects dose of lacosamide may be increased, or decreased, as needed to maintain a subject's effective and tolerable dose during the study.
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Drug: lacosamide
50mg or 100mg tablets; 100mg/day up to 800mg/day given as BID dosing throughout the trial.
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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 who were previously enrolled in the SP925 trial (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).
Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |||||
Baltimore, Maryland, United States | |||||
United States, Missouri | |||||
Chesterfield, Missouri, United States | |||||
United States, Ohio | |||||
Columbus, Ohio, United States | |||||
Cleveland, Ohio, United States | |||||
United States, Pennsylvania | |||||
Philadelphia, Pennsylvania, United States | |||||
United States, Tennessee | |||||
Nashville, Tennessee, United States | |||||
United States, Texas | |||||
Dallas, Texas, United States | |||||
United States, Virginia | |||||
Charlottesville, Virginia, United States |
UCB |
Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Responsible Party: | UCB ( Study Director ) |
Study ID Numbers: | SP926 |
First Received: | March 26, 2008 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00655486 |
Health Authority: | United States: Food and Drug Administration |
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