Clinical trial NCT00530855: Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
Partial-onset Seizures
Lacosamide
Monotherapy
Vimpat
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 322
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)

Primary outcomes:
measure: Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study
timeFrame: From Visit 1 to End of Study (approximately 2 years)
measure: Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study
timeFrame: From Visit 1 to End of Study (approximately 2 years)
Secondary outcomes:
measure: Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study
timeFrame: From Visit 1 to End of Study (approximately 2 years)
measure: Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study
timeFrame: From Visit 1 to End of Study (approximately 2 years)
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: 048
state: Alabama
city: Birmingham
country: United States
facility: 010
state: Alabama
city: Northport
country: United States
facility: 042
state: Alabama
city: Phoenix
country: United States
facility: 009
state: Arizona
city: Phoenix
country: United States
facility: 014
state: Arizona
city: Phoenix
country: United States
facility: 151
state: Arizona
city: Tucson
country: United States
facility: 103
state: Arizona
city: Jonesboro
country: United States
facility: 102
state: Arkansas
city: Little Rock
country: United States
facility: 007
state: Arkansas
city: Little Rock
country: United States
facility: 086
state: Arkansas
city: La Habra
country: United States
facility: 120
state: California
city: Los Angeles
country: United States
facility: 059
state: California
city: Santa Monica
country: United States
facility: 021
state: California
city: Torrance
country: United States
facility: 107
state: California
city: Aurora
country: United States
facility: 060
state: Colorado
city: Fairfield
country: United States
facility: 025
state: Connecticut
city: Doral
country: United States
facility: 094
state: Florida
city: Gainesville
country: United States
facility: 108
state: Florida
city: Miami
country: United States
facility: 123
state: Florida
city: Miami
country: United States
facility: 132
state: Florida
city: Orlando
country: United States
facility: 077
state: Florida
city: Panama City
country: United States
facility: 049
state: Florida
city: Port Charlotte
country: United States
facility: 129
state: Florida
city: Sarasota
country: United States
facility: 050
state: Florida
city: Tallahassee
country: United States
facility: 004
state: Florida
city: Atlanta
country: United States
facility: 079
state: Georgia
city: Boise
country: United States
facility: 058
state: Idaho
city: Hines
country: United States
facility: 131
state: Illinois
city: Peoria
country: United States
facility: 146
state: Illinois
city: Springfield
country: United States
facility: 011
state: Illinois
city: Indianapolis
country: United States
facility: 078
state: Indiana
city: Ames
country: United States
facility: 073
state: Iowa
city: Manhattan
country: United States
facility: 124
state: Kansas
city: Wichita
country: United States
facility: 023
state: Kansas
city: Wichita
country: United States
facility: 160
state: Kansas
city: Lexington
country: United States
facility: 164
state: Kentucky
city: Louisville
country: United States
facility: 062
state: Kentucky
city: Scarborough
country: United States
facility: 029
state: Maine
city: Baltimore
country: United States
facility: 020
state: Maryland
city: Baltimore
country: United States
facility: 034
state: Maryland
city: Pikesville
country: United States
facility: 065
state: Maryland
city: Waldorf
country: United States
facility: 137
state: Maryland
city: Detroit
country: United States
facility: 041
state: Michigan
city: Golden Valley
country: United States
facility: 030
state: Minnesota
city: Hattiesburg
country: United States
facility: 071
state: Mississippi
city: Chesterfield
country: United States
facility: 031
state: Missouri
city: Saint Louis
country: United States
facility: 066
state: Missouri
city: Lebanon
country: United States
facility: 017
state: New Hampshire
city: Voorhees
country: United States
facility: 067
state: New Jersey
city: Albany
country: United States
facility: 036
state: New York
city: Buffalo
country: United States
facility: 083
state: New York
city: Cedarhurst
country: United States
facility: 069
state: New York
city: New York
country: United States
facility: 027
state: New York
city: New York
country: United States
facility: 122
state: New York
city: Asheville
country: United States
facility: 003
state: North Carolina
city: Durham
country: United States
facility: 063
state: North Carolina
city: Wilmington
country: United States
facility: 117
state: North Carolina
city: Cleveland
country: United States
facility: 015
state: Ohio
city: Columbus
country: United States
facility: 061
state: Ohio
city: Toledo
country: United States
facility: 002
state: Ohio
city: Oklahoma City
country: United States
facility: 147
state: Oklahoma
city: Greensburg
country: United States
facility: 100
state: Pennsylvania
city: Philadelphia
country: United States
facility: 032
state: Pennsylvania
city: Beaufort
country: United States
facility: 024
state: South Carolina
city: Chattanooga
country: United States
facility: 114
state: Tennessee
city: Nashville
country: United States
facility: 001
state: Tennessee
city: Austin
country: United States
facility: 138
state: Texas
city: Dallas
country: United States
facility: 022
state: Texas
city: El Paso
country: United States
facility: 046
state: Texas
city: Houston
country: United States
facility: 051
state: Texas
city: Houston
country: United States
facility: 053
state: Texas
city: San Antonio
country: United States
facility: 098
state: Texas
city: Layton
country: United States
facility: 136
state: Utah
city: Alexandria
country: United States
facility: 161
state: Virginia
city: Charlottesville
country: United States
facility: 016
state: Virginia
city: Renton
country: United States
facility: 074
state: Washington
city: Madison
country: United States
facility: 080
state: Wisconsin
city: Capmerdown
country: Australia
facility: 421
state: New South Wales
city: Chatswood
country: Australia
facility: 425
state: New South Wales
city: Herston
country: Australia
facility: 423
state: Queensland
city: Adelaide
country: Australia
facility: 420
state: South Australia
city: Parkville
country: Australia
facility: 427
state: Victoria
city: Halifax
country: Canada
facility: 140
state: Nova Scotia
city: Hamilton
country: Canada
facility: 116
state: Ontario
city: London
country: Canada
facility: 093
state: Ontario
city: Greenfield Park
country: Canada
facility: 091
state: Quebec
city: Montreal
country: Canada
facility: 110
state: Quebec
city: Montreal
country: Canada
facility: 113
state: Quebec
city: Calgary
country: Canada
facility: 127
city: Aarhus
country: Denmark
facility: 223
city: Mainz
country: Germany
facility: 461
city: Ferrara
country: Italy
facility: 443
city: Reggio Calabria
country: Italy
facility: 445
city: Torrette Di Ancona
country: Italy
facility: 447
city: Czestochowa
country: Poland
facility: 284
city: Gdansk
country: Poland
facility: 286
city: Gdynia
country: Poland
facility: 282
city: Krakow
country: Poland
facility: 280
city: Lublin
country: Poland
facility: 290
city: Szczecin
country: Poland
facility: 289
city: Warszawa
country: Poland
facility: 281
city: Warszawa
country: Poland
facility: 287
city: Santa Cruz de Tenerife
country: Spain
facility: 324
city: Blackpool
country: United Kingdom
facility: 360
city: Cornwall
country: United Kingdom
facility: 367
city: London
country: United Kingdom
facility: 364
city: London
country: United Kingdom
facility: 369
city: Middlesborough
country: United Kingdom
facility: 363
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: