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Sponsored by: |
UCB |
Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00655551 |
The purpose of the trial is to evaluate the safety of iv lacosamide delivered in a single dose followed by 6,5 days of oral dosing with lacosamide in patients with partial-onset seizures.
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, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Multicenter, Open-Label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Lacosamide Maintenance as Adjunctive Therapy in Subjects With Partial-Onset Seizures |
Estimated Enrollment: | 100 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
One bolus dose of iv lacosamide followed by 6.5 days of oral lacosamide
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Drug: lacosamide
iv lacosamide 200mg one bolus dose administered over a 15 minute infusion duration followed by oral lacosamide 200mg/day (100mg bid) for 6.5 days
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2: Experimental
One bolus dose of iv lacosamide followed by 6.5 days of oral lacosamide
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Drug: lacosamide
iv lacosamide 300mg one bolus dose administered over a 15 minute infusion duration followed by oral lacosamide300mg/day (150mg bid) for 6.5 days
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3: Experimental
One bolus dose of iv lacosamide followed by 6.5 days of oral lacosamide
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Drug: lacosamide
iv lacosamide 400mg one bolus dose administered over a 15 minute infusion duration followed by oral lacosamide 400mg/day (200mg bid) for 6.5 days
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4: Experimental
One bolus dose of iv lacosamide followed by 6.5 days of oral lacosamide
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Drug: lacosamide
TBD A DMC review will determine if the trial should be ended or which of the 3 cohorts will be repeated. The repeated cohort will be the highest dose that produces clinically acceptable safety results.
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A multicenter, open-label trial designed to assess the safety and tolerability of rapid initiation of adjunctive lacosamide via a single iv loading dose (iv lacosamide 200mg, 300mg, or 400mg administered over a 15-minute infusion duration) followed by twice daily oral lacosamide dosing (daily dose equivalent to the iv loading dose) in adults subjects 16 - 60 years of age with partial-onset seizures.
Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: UCB Clinical Trial Call Center | +1 877 822 9493 |
United States, Maryland | |||||
Recruiting | |||||
Baltimore, Maryland, United States | |||||
United States, Missouri | |||||
Recruiting | |||||
Chesterfield, Missouri, United States | |||||
United States, Ohio | |||||
Recruiting | |||||
Columbus, Ohio, United States | |||||
Recruiting | |||||
Cleveland, Ohio, United States | |||||
United States, Pennsylvania | |||||
Recruiting | |||||
Philadelphia, Pennsylvania, United States | |||||
United States, Tennessee | |||||
Active, not recruiting | |||||
Nashville, Tennessee, United States | |||||
United States, Texas | |||||
Recruiting | |||||
Dallas, Texas, United States | |||||
United States, Virginia | |||||
Recruiting | |||||
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: | SP925 |
First Received: | March 26, 2008 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00655551 |
Health Authority: | United States: Food and Drug Administration |
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