Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
- Registration Number
- NCT00530855
- Lead Sponsor
- UCB Pharma
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 322
- 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)
- Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lacosamide Lacosamide Lacosamide tablets for dosing 100 -800 mg/day
- Primary Outcome Measures
Name Time Method 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) Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study From Visit 1 to End of Study (approximately 2 years) Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
- Secondary Outcome Measures
Name Time Method 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) A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.
An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).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)
Trial Locations
- Locations (108)
137
🇺🇸Waldorf, Maryland, United States
094
🇺🇸Doral, Florida, United States
029
🇺🇸Scarborough, Maine, United States
031
🇺🇸Chesterfield, Missouri, United States
003
🇺🇸Asheville, North Carolina, United States
015
🇺🇸Cleveland, Ohio, United States
022
🇺🇸Dallas, Texas, United States
024
🇺🇸Beaufort, South Carolina, United States
078
🇺🇸Indianapolis, Indiana, United States
051
🇺🇸Houston, Texas, United States
160
🇺🇸Wichita, Kansas, United States
284
🇵🇱Czestochowa, Poland
290
🇵🇱Lublin, Poland
009
🇺🇸Phoenix, Arizona, United States
151
🇺🇸Phoenix, Arizona, United States
147
🇺🇸Oklahoma City, Oklahoma, United States
010
🇺🇸Birmingham, Alabama, United States
425
🇦🇺Chatswood, New South Wales, Australia
107
🇺🇸Torrance, California, United States
421
🇦🇺Capmerdown, New South Wales, Australia
423
🇦🇺Herston, Queensland, Australia
004
🇺🇸Tallahassee, Florida, United States
049
🇺🇸Panama City, Florida, United States
023
🇺🇸Wichita, Kansas, United States
083
🇺🇸Buffalo, New York, United States
050
🇺🇸Sarasota, Florida, United States
420
🇦🇺Adelaide, South Australia, Australia
427
🇦🇺Parkville, Victoria, Australia
369
🇬🇧London, United Kingdom
058
🇺🇸Boise, Idaho, United States
079
🇺🇸Atlanta, Georgia, United States
041
🇺🇸Detroit, Michigan, United States
011
🇺🇸Springfield, Illinois, United States
124
🇺🇸Manhattan, Kansas, United States
443
🇮🇹Ferrara, Italy
113
🇨🇦Montreal, Quebec, Canada
131
🇺🇸Hines, Illinois, United States
280
🇵🇱Krakow, Poland
065
🇺🇸Pikesville, Maryland, United States
069
🇺🇸Cedarhurst, New York, United States
066
🇺🇸Saint Louis, Missouri, United States
071
🇺🇸Hattiesburg, Mississippi, United States
461
🇩🇪Mainz, Germany
067
🇺🇸Voorhees, New Jersey, United States
447
🇮🇹Torrette Di Ancona, Italy
117
🇺🇸Wilmington, North Carolina, United States
360
🇬🇧Blackpool, United Kingdom
289
🇵🇱Szczecin, Poland
001
🇺🇸Nashville, Tennessee, United States
053
🇺🇸Houston, Texas, United States
042
🇺🇸Northport, Alabama, United States
281
🇵🇱Warszawa, Poland
014
🇺🇸Phoenix, Arizona, United States
007
🇺🇸Little Rock, Arkansas, United States
287
🇵🇱Warszawa, Poland
161
🇺🇸Alexandria, Virginia, United States
021
🇺🇸Santa Monica, California, United States
363
🇬🇧Middlesborough, United Kingdom
140
🇨🇦Halifax, Nova Scotia, Canada
110
🇨🇦Montreal, Quebec, Canada
127
🇨🇦Calgary, Canada
122
🇺🇸New York, New York, United States
048
🇺🇸Alabaster, Alabama, United States
103
🇺🇸Tucson, Arizona, United States
120
🇺🇸La Habra, California, United States
086
🇺🇸Little Rock, Arkansas, United States
059
🇺🇸Los Angeles, California, United States
025
🇺🇸Fairfield, Connecticut, United States
123
🇺🇸Miami, Florida, United States
108
🇺🇸Gainesville, Florida, United States
132
🇺🇸Miami, Florida, United States
077
🇺🇸Orlando, Florida, United States
129
🇺🇸Port Charlotte, Florida, United States
073
🇺🇸Ames, Iowa, United States
020
🇺🇸Baltimore, Maryland, United States
034
🇺🇸Baltimore, Maryland, United States
030
🇺🇸Golden Valley, Minnesota, United States
017
🇺🇸Lebanon, New Hampshire, United States
036
🇺🇸Albany, New York, United States
027
🇺🇸New York, New York, United States
063
🇺🇸Durham, North Carolina, United States
061
🇺🇸Columbus, Ohio, United States
100
🇺🇸Greensburg, Pennsylvania, United States
114
🇺🇸Chattanooga, Tennessee, United States
136
🇺🇸Layton, Utah, United States
138
🇺🇸Austin, Texas, United States
098
🇺🇸San Antonio, Texas, United States
046
🇺🇸El Paso, Texas, United States
016
🇺🇸Charlottesville, Virginia, United States
080
🇺🇸Madison, Wisconsin, United States
074
🇺🇸Renton, Washington, United States
091
🇨🇦Greenfield Park, Quebec, Canada
223
🇩🇰Aarhus, Denmark
445
🇮🇹Reggio Calabria, Italy
286
🇵🇱Gdansk, Poland
282
🇵🇱Gdynia, Poland
324
🇪🇸Santa Cruz de Tenerife, Spain
364
🇬🇧London, United Kingdom
367
🇬🇧Cornwall, United Kingdom
002
🇺🇸Toledo, Ohio, United States
146
🇺🇸Peoria, Illinois, United States
102
🇺🇸Jonesboro, Arkansas, United States
116
🇨🇦Hamilton, Ontario, Canada
032
🇺🇸Philadelphia, Pennsylvania, United States
093
🇨🇦London, Ontario, Canada
060
🇺🇸Aurora, Colorado, United States
062
🇺🇸Louisville, Kentucky, United States
164
🇺🇸Lexington, Kentucky, United States