Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures
2 other identifiers
interventional
322
9 countries
108
Brief Summary
This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).
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 Feb 2008
Longer than P75 for phase_3
108 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
First Submitted
Initial submission to the registry
September 14, 2007
CompletedFirst Posted
Study publicly available on registry
September 18, 2007
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
June 3, 2015
CompletedJuly 18, 2018
July 1, 2017
6.8 years
September 14, 2007
May 18, 2015
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study
Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
From Visit 1 to End of Study (approximately 2 years)
Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study
Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
From Visit 1 to End of Study (approximately 2 years)
Secondary Outcomes (2)
Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study
From Visit 1 to End of Study (approximately 2 years)
Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study
From Visit 1 to End of Study (approximately 2 years)
Study Arms (1)
Lacosamide
EXPERIMENTALLacosamide tablets for dosing 100 -800 mg/day
Interventions
50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years
Eligibility Criteria
You may qualify if:
- Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)
You may not qualify if:
- Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (108)
048
Alabaster, Alabama, United States
010
Birmingham, Alabama, United States
042
Northport, Alabama, United States
009
Phoenix, Arizona, United States
014
Phoenix, Arizona, United States
151
Phoenix, Arizona, United States
103
Tucson, Arizona, United States
102
Jonesboro, Arkansas, United States
007
Little Rock, Arkansas, United States
086
Little Rock, Arkansas, United States
120
La Habra, California, United States
059
Los Angeles, California, United States
021
Santa Monica, California, United States
107
Torrance, California, United States
060
Aurora, Colorado, United States
025
Fairfield, Connecticut, United States
094
Doral, Florida, United States
108
Gainesville, Florida, United States
123
Miami, Florida, United States
132
Miami, Florida, United States
077
Orlando, Florida, United States
049
Panama City, Florida, United States
129
Port Charlotte, Florida, United States
050
Sarasota, Florida, United States
004
Tallahassee, Florida, United States
079
Atlanta, Georgia, United States
058
Boise, Idaho, United States
131
Hines, Illinois, United States
146
Peoria, Illinois, United States
011
Springfield, Illinois, United States
078
Indianapolis, Indiana, United States
073
Ames, Iowa, United States
124
Manhattan, Kansas, United States
023
Wichita, Kansas, United States
160
Wichita, Kansas, United States
164
Lexington, Kentucky, United States
062
Louisville, Kentucky, United States
029
Scarborough, Maine, United States
020
Baltimore, Maryland, United States
034
Baltimore, Maryland, United States
065
Pikesville, Maryland, United States
137
Waldorf, Maryland, United States
041
Detroit, Michigan, United States
030
Golden Valley, Minnesota, United States
071
Hattiesburg, Mississippi, United States
031
Chesterfield, Missouri, United States
066
St Louis, Missouri, United States
017
Lebanon, New Hampshire, United States
067
Voorhees Township, New Jersey, United States
036
Albany, New York, United States
083
Buffalo, New York, United States
069
Cedarhurst, New York, United States
027
New York, New York, United States
122
New York, New York, United States
003
Asheville, North Carolina, United States
063
Durham, North Carolina, United States
117
Wilmington, North Carolina, United States
015
Cleveland, Ohio, United States
061
Columbus, Ohio, United States
002
Toledo, Ohio, United States
147
Oklahoma City, Oklahoma, United States
100
Greensburg, Pennsylvania, United States
032
Philadelphia, Pennsylvania, United States
024
Beaufort, South Carolina, United States
114
Chattanooga, Tennessee, United States
001
Nashville, Tennessee, United States
138
Austin, Texas, United States
022
Dallas, Texas, United States
046
El Paso, Texas, United States
051
Houston, Texas, United States
053
Houston, Texas, United States
098
San Antonio, Texas, United States
136
Layton, Utah, United States
161
Alexandria, Virginia, United States
016
Charlottesville, Virginia, United States
074
Renton, Washington, United States
080
Madison, Wisconsin, United States
421
Capmerdown, New South Wales, Australia
425
Chatswood, New South Wales, Australia
423
Herston, Queensland, Australia
420
Adelaide, South Australia, Australia
427
Parkville, Victoria, Australia
140
Halifax, Nova Scotia, Canada
116
Hamilton, Ontario, Canada
093
London, Ontario, Canada
091
Greenfield Park, Quebec, Canada
110
Montreal, Quebec, Canada
113
Montreal, Quebec, Canada
127
Calgary, Canada
223
Aarhus, Denmark
461
Mainz, Germany
443
Ferrara, Italy
445
Reggio Calabria, Italy
447
Torrette Di Ancona, Italy
284
Częstochowa, Poland
286
Gdansk, Poland
282
Gdynia, Poland
280
Krakow, Poland
290
Lublin, Poland
289
Szczecin, Poland
281
Warsaw, Poland
287
Warsaw, Poland
324
Santa Cruz de Tenerife, Spain
360
Blackpool, United Kingdom
367
Cornwall, United Kingdom
364
London, United Kingdom
369
London, United Kingdom
363
Middlesbrough, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB Pharma
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- 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
September 14, 2007
First Posted
September 18, 2007
Study Start
February 1, 2008
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
July 18, 2018
Results First Posted
June 3, 2015
Record last verified: 2017-07