Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
NCT ID: NCT01118949
Last Updated: 2018-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2010-05-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lacosamide
Lacosamide
Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Interventions
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Lacosamide
Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has ≥1 PGTC seizure within the 12 weeks prior to the screening visit
* Subject has a stable dose regimen of 1 to 3 marketed antiepileptic drug(s) (AEDs) with or without additional concurrent stable Vagus Nerve Stimulation (VNS). The VNS must have been in place for at least 6 months prior to study entry with constant settings for at least 28 days prior to the screening visit and during the Baseline Phase. Benzodiazepines will be counted as an AED
Exclusion Criteria
* Subject has a history of status epilepticus within the 5-year Period prior to Visit 1
* Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events
* Subject has any medical or psychiatric condition
* Subject has any history of alcohol or drug abuse
* Subject is currently taking felbamate
* Subject has ever taken vigabatrin and has no visual fields examination report available or if results of the examination are abnormal
* Subject is on a ketogenic diet
* Subject has a known sodium channelopathy
16 Years
65 Years
ALL
No
Sponsors
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UCB BIOSCIENCES, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Alabaster, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
San Francisco, California, United States
Aurora, Colorado, United States
Atlanta, Georgia, United States
Rome, Georgia, United States
Boise, Idaho, United States
Fort Wayne, Indiana, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Scarborough, Maine, United States
Bethesda, Maryland, United States
Chesterfield, Missouri, United States
New York, New York, United States
Columbus, Ohio, United States
Hershey, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Renton, Washington, United States
Madison, Wisconsin, United States
Countries
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References
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Wechsler RT, Yates SL, Messenheimer J, Leroy R, Beller C, Doty P. Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension. Epilepsy Res. 2017 Feb;130:13-20. doi: 10.1016/j.eplepsyres.2016.12.015. Epub 2016 Dec 29.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2014-004379-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0961
Identifier Type: -
Identifier Source: org_study_id
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