To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures
1 other identifier
interventional
370
8 countries
59
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 P75+ for phase_2
Started Aug 2001
Longer than P75 for phase_2
59 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
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 30, 2007
CompletedFirst Posted
Study publicly available on registry
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
September 2, 2011
CompletedJuly 17, 2018
July 1, 2017
8.5 years
October 30, 2007
February 23, 2011
June 20, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 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 (up to 8 years)
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 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 (up to 8 years)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
During the Treatment Period (up to 8 years)
Secondary Outcomes (2)
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)
Baseline, End of Treatment Period (up to 8 years)
Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)
Treatment Period (up to 8 years)
Study Arms (1)
Lacosamide
EXPERIMENTAL50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing
Interventions
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing 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
- UCB Pharmalead
Study Sites (59)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
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Little Rock, Arkansas, United States
Unknown Facility
Los Angeles, California, United States
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Englewood, Colorado, United States
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Gainesville, Florida, United States
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Hollywood, Florida, United States
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Miami, Florida, United States
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Ponte Vedra Beach, Florida, 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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Iowa City, Iowa, United States
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Wichita, Kansas, United States
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Crestview Hills, Kentucky, United States
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Lexington, Kentucky, United States
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Baltimore, Maryland, United States
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Frederick, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Saint Paul, Minnesota, United States
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Chesterfield, Missouri, United States
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St Louis, Missouri, United States
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Somerset, New Jersey, United States
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New York, New York, United States
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Durham, 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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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Irving, Texas, United States
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Lubbock, Texas, United States
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Wichita Falls, Texas, United States
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Bennington, Vermont, United States
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Charlottesville, Virginia, United States
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Marshfield, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Bonn, Germany
Unknown Facility
Erlangen, Germany
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Kehl Kork, Germany
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Schwalmstedt-Treysa, Germany
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Budapest, Hungary
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Zalaegerszeg, Hungary
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Kaunas, Lithuania
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Vilnius, Lithuania
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Poznan, Poland
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Gothenburg, Sweden
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Stockholm, Sweden
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Bern/Biel, Switzerland
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Zurich, Switzerland
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Bucks/London, United Kingdom
Unknown Facility
Glasgow, United Kingdom
Unknown Facility
Liverpool, United Kingdom
Related Publications (1)
Rosenfeld W, Fountain NB, Kaubrys G, Ben-Menachem E, McShea C, Isojarvi J, Doty P; SP615 Study Investigators. Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years. Epilepsy Behav. 2014 Dec;41:164-70. doi: 10.1016/j.yebeh.2014.09.074. Epub 2014 Oct 27.
PMID: 25461210DERIVED
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
October 30, 2007
First Posted
November 1, 2007
Study Start
August 1, 2001
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
July 17, 2018
Results First Posted
September 2, 2011
Record last verified: 2017-07