Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
An Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Long-Term Oral Lacosamide for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
2 other identifiers
interventional
39
1 country
19
Brief Summary
The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2010
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2010
CompletedFirst Posted
Study publicly available on registry
May 7, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
December 4, 2013
CompletedJuly 17, 2018
March 1, 2018
2.2 years
May 5, 2010
October 7, 2013
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)
From Visit 1 to the end of study (Approximately 61 weeks)
Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)
From Visit 1 to the end of study (Approximately 61 weeks)
Study Arms (1)
Lacosamide
EXPERIMENTALLacosamide 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Subject completed the SP0961 (NCT01118949) study
- Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator
You may not qualify if:
- Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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
Related Publications (1)
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.
PMID: 28086164RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
May 5, 2010
First Posted
May 7, 2010
Study Start
August 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
July 17, 2018
Results First Posted
December 4, 2013
Record last verified: 2018-03