Trial to Assess the Safety of a Single Dose of iv Lacosamide Followed by Twice Daily Oral Lacosamide in Patients With Partial-onset Seizures - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00655551

Purpose

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Adverse events as reported spontaneously by the patient and/or caregiver or observed by the investigator, subject withdrawals due to AEs [ Time Frame: 10 days to up to 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in hematology, chemistry and urinalysis; changes in ECGs and vital signs; plasma concentrations of lacosamide [ Time Frame: 10 days to up to 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	March 2008
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lacosamide IV and 200mg tablet: Experimental One bolus dose of iv lacosamide followed by 6.5 days of oral lacosamide	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
Lacosamide IV and 300mg tablet: Experimental One bolus dose of iv lacosamide followed by 6.5 days of oral lacosamide	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
Lacosamide IV and 400mg tablet: Experimental One bolus dose of iv lacosamide followed by 6.5 days of oral lacosamide	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
Repeat Cohort: Experimental One bolus dose of iv lacosamide followed by 6.5 days of oral lacosamide	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures
stable dose regimen of 1 to 2 marketed AEDs for 28 days prior to screening and duration of trial
acceptable candidate for venipuncture and iv infusion
at least 1 partial seizure with motor component per 90 days
maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type.

Exclusion Criteria:

Previous use of lacosamide
history of primary generalized seizures
history of status epilepticus within last 12 months; history of cluster seizures during 8 week period prior to screening
nonepileptic events, including psychogenic seizures that could be confused with seizures
use of neuroleptics, MOA inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening
received any rescue benzodiazepines more than once during the 28 days prior to screening
concomitant treatment of felbamate or previous felbamate therapy within last 6 months
prior or concomitant vigabatrin use.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655551

Locations

United States, Arizona

Phoenix, Arizona, United States
United States, Maryland

Baltimore, Maryland, United States

Baltimore, Maryland, United States
United States, Missouri

Chesterfield, Missouri, United States
United States, Ohio

Columbus, Ohio, United States
United States, Pennsylvania

Philadelphia, Pennsylvania, United States
United States, Texas

Dallas, Texas, United States
United States, Virginia

Charlottesville, Virginia, United States

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP925
Study First Received:	March 26, 2008
Last Updated:	September 28, 2009
ClinicalTrials.gov Identifier:	NCT00655551 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Adjunctive treatment in epilepsy
add-on treatment for epilepsy
partial seizures
AEDs

antiepileptic drugs
seizures
Vimpat
iv AED

Additional relevant MeSH terms:

Epilepsies, Partial
Signs and Symptoms
Epilepsy
Nervous System Diseases

Seizures
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on February 08, 2010