Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures
2 other identifiers
interventional
308
1 country
60
Brief Summary
The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2004
Longer than P75 for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 27, 2007
CompletedFirst Posted
Study publicly available on registry
August 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
November 22, 2010
CompletedJuly 18, 2018
July 1, 2017
5 years
August 27, 2007
October 28, 2010
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
During the Treatment Period (Maximum 6 years)
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
During the Treatment Period (Maximum 6 years)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)
Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
During the Treatment Period (Maximum 6 years)
Secondary Outcomes (2)
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)
Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)
Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)
Treatment Period (Maximum 6 years)
Study Arms (1)
Lacosamide
EXPERIMENTALUp to 800 mg/day lacosamide (flexible dosing)
Interventions
50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial
Eligibility Criteria
You may qualify if:
- Completion of parent clinical trial for treatment of partial seizures
You may not qualify if:
- Receiving any study drug or experimental device other than lacosamide
- Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Englewood, Colorado, United States
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Fairfield, Connecticut, United States
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Bradenton, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Golden Valley, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Saint Paul, Minnesota, United States
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Chesterfield, Missouri, United States
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Somerset, New Jersey, United States
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Albuquerque, New Mexico, United States
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Buffalo, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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Asheville, North Carolina, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Tulsa, Oklahoma, United States
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Medford, Oregon, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Providence, Rhode Island, United States
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Beaufort, South Carolina, United States
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Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Charlottesville, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Morgantown, West Virginia, United States
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Marshfield, Wisconsin, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Related Publications (1)
Husain A, Chung S, Faught E, Isojarvi J, McShea C, Doty P. Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia. 2012 Mar;53(3):521-8. doi: 10.1111/j.1528-1167.2012.03407.x.
PMID: 22372628RESULT
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 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 27, 2007
First Posted
August 29, 2007
Study Start
October 1, 2004
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
July 18, 2018
Results First Posted
November 22, 2010
Record last verified: 2017-07