Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
NCT ID: NCT01118962
Last Updated: 2018-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2010-08-31
2012-10-31
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 was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
Lacosamide
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100 mg /day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/ day per week up to a maximum of 800 mg/ day. Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase was followed by a 5-week End-of-Study Phase, during which subjects had to be tapered off Lacosamide at a recommended decrease rate of 200 mg/ day per week.
Interventions
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Lacosamide
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100 mg /day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/ day per week up to a maximum of 800 mg/ day. Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase was followed by a 5-week End-of-Study Phase, during which subjects had to be tapered off Lacosamide at a recommended decrease rate of 200 mg/ day per week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator
Exclusion Criteria
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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603
Phoenix, Arizona, United States
602
Little Rock, Arkansas, United States
628
Aurora, Colorado, United States
613
Atlanta, Georgia, United States
617
Boise, Idaho, United States
614
Fort Wayne, Indiana, United States
605
Lexington, Kentucky, United States
616
Louisville, Kentucky, United States
619
Scarborough, Maine, United States
609
Bethesda, Maryland, United States
615
Chesterfield, Missouri, United States
607
New York, New York, United States
620
Columbus, Ohio, United States
608
Charleston, South Carolina, United States
601
Nashville, Tennessee, United States
612
Dallas, Texas, United States
610
Norfolk, Virginia, United States
623
Renton, Washington, United States
624
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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2014-004375-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0962
Identifier Type: -
Identifier Source: org_study_id
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