Clinical trial NCT00520741: Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
Official title: A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400 mg/Day Monotherapy 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: 2007-08-27
Enrollment: 426
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Detailed description: Sudden unexplained death in epilepsy have been reported in epilepsy patients. A causal relationship with the administration of antiepileptic drugs has not been established. The most important known risk factor for sudden unexplained death in epilepsy (SUDEP) is the occurrence and frequency of generalized tonic-clonic seizures (GTCS). Twenty-seven patients with only GTCS were enrolled in the conversion to monotherapy study. In this study, two patients with only GTCS had SUDEP. Due to the potential increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.

Eligibility criteria: Inclusion Criteria:

* Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and or Complex Partial Seizures (with or without secondary generalization)
* Must be experiencing 2 to 40 seizures per 28-day period
* Stable dose of 1 or 2 marketed antiepileptic drugs
* Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA product label at screening

Exclusion Criteria:

* Subject has a history of primary generalized or unclassified seizures
* Seizure disorder primarily characterized by isolated auras
* History of status epilepticus
* Seizures that are uncountable due to clustering
* Has greater than 5 seizures/day
* Subjects taking Benzodiazepines, Phenobarbital or Primidone
* Subject has Vagus Nerve Stimulation (VNS)
* Significant medical or psychiatric condition
* History of alcohol or drug abuse
* History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997

Primary outcomes:
measure: Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)
timeFrame: 16 Weeks Maintenance Period (approximately 112 days)
Secondary outcomes:
measure: Time to First Occurrence of Any Exit Event During The Maintenance Period
timeFrame: 16 Weeks Maintenance Period (approximately 112 days)
measure: Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period
timeFrame: 16 Weeks Maintenance Period (approximately 112 days)
measure: Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)
timeFrame: Visit 9 - Visit 12 (approximately 10 weeks)
measure: Clinical Global Impression of Change (CGIC) From Baseline To Last Visit
timeFrame: Baseline; Last Visit (approximately 27 weeks)
measure: Patient's Global Impression of Change (PGIC) From Baseline To Last Visit
timeFrame: Baseline; Last Visit (approximately 27 weeks)
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: 48
state: Alabama
city: Birmingham
country: United States
facility: 10
state: Alabama
city: Huntsville
country: United States
facility: 18
state: Alabama
city: Northport
country: United States
facility: 42
state: Alabama
city: Phoenix
country: United States
facility: 14
state: Arizona
city: Phoenix
country: United States
facility: 151
state: Arizona
city: Phoenix
country: United States
facility: 9
state: Arizona
city: Sun City
country: United States
facility: 150
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: 7
state: Arkansas
city: Little Rock
country: United States
facility: 86
state: Arkansas
city: La Habra
country: United States
facility: 120
state: California
city: Loma Linda
country: United States
facility: 156
state: California
city: Los Angeles
country: United States
facility: 59
state: California
city: Los Angeles
country: United States
facility: 76
state: California
city: Newport Beach
country: United States
facility: 45
state: California
city: Santa Monica
country: United States
facility: 21
state: California
city: Torrance
country: United States
facility: 107
state: California
city: Aurora
country: United States
facility: 60
state: Colorado
city: Fairfield
country: United States
facility: 25
state: Connecticut
city: Dover
country: United States
facility: 133
state: Delaware
city: Washington
country: United States
facility: 37
state: District of Columbia
city: Doral
country: United States
facility: 94
state: Florida
city: Gainesville
country: United States
facility: 108
state: Florida
city: Gulf Breeze
country: United States
facility: 130
state: Florida
city: Maitland
country: United States
facility: 55
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: 77
state: Florida
city: Panama City
country: United States
facility: 49
state: Florida
city: Pinellas Park
country: United States
facility: 109
state: Florida
city: Port Charlotte
country: United States
facility: 129
state: Florida
city: Sarasota
country: United States
facility: 50
state: Florida
city: Sarasota
country: United States
facility: 81
state: Florida
city: Tallahassee
country: United States
facility: 4
state: Florida
city: Tampa
country: United States
facility: 163
state: Florida
city: Atlanta
country: United States
facility: 79
state: Georgia
city: Canton
country: United States
facility: 72
state: Georgia
city: Savannah
country: United States
facility: 40
state: Georgia
city: Boise
country: United States
facility: 58
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: 11
state: Illinois
city: Indianapolis
country: United States
facility: 78
state: Indiana
city: Ames
country: United States
facility: 73
state: Iowa
city: Manhattan
country: United States
facility: 124
state: Kansas
city: Wichita
country: United States
facility: 160
state: Kansas
city: Wichita
country: United States
facility: 23
state: Kansas
city: Lexington
country: United States
facility: 119
state: Kentucky
city: Lexington
country: United States
facility: 164
state: Kentucky
city: Louisville
country: United States
facility: 62
state: Kentucky
city: Scarborough
country: United States
facility: 29
state: Maine
city: Baltimore
country: United States
facility: 20
state: Maryland
city: Baltimore
country: United States
facility: 34
state: Maryland
city: Bethesda
country: United States
facility: 19
state: Maryland
city: Pikesville
country: United States
facility: 65
state: Maryland
city: Waldorf
country: United States
facility: 137
state: Maryland
city: Detroit
country: United States
facility: 41
state: Michigan
city: Golden Valley
country: United States
facility: 30
state: Minnesota
city: Hattiesburg
country: United States
facility: 71
state: Mississippi
city: Chesterfield
country: United States
facility: 31
state: Missouri
city: Columbia
country: United States
facility: 105
state: Missouri
city: Saint Louis
country: United States
facility: 66
state: Missouri
city: Omaha
country: United States
facility: 174
state: Nebraska
city: Lebanon
country: United States
facility: 17
state: New Hampshire
city: Edison
country: United States
facility: 43
state: New Jersey
city: Voorhees
country: United States
facility: 67
state: New Jersey
city: Albany
country: United States
facility: 36
state: New York
city: Buffalo
country: United States
facility: 83
state: New York
city: Cedarhurst
country: United States
facility: 69
state: New York
city: Mineola
country: United States
facility: 154
state: New York
city: New York
country: United States
facility: 122
state: New York
city: New York
country: United States
facility: 27
state: New York
city: Schenectady
country: United States
facility: 175
state: New York
city: Asheville
country: United States
facility: 3
state: North Carolina
city: Durham
country: United States
facility: 63
state: North Carolina
city: Rocky Mount
country: United States
facility: 152
state: North Carolina
city: Wilmington
country: United States
facility: 117
state: North Carolina
city: Winston-Salem
country: United States
facility: 47
state: North Carolina
city: Cleveland
country: United States
facility: 15
state: Ohio
city: Columbus
country: United States
facility: 61
state: Ohio
city: Toledo
country: United States
facility: 2
state: Ohio
city: Oklahoma City
country: United States
facility: 147
state: Oklahoma
city: Medford
country: United States
facility: 8
state: Oregon
city: Portland
country: United States
facility: 157
state: Oregon
city: Greensburg
country: United States
facility: 100
state: Pennsylvania
city: Philadelphia
country: United States
facility: 32
state: Pennsylvania
city: Tarentum
country: United States
facility: 26
state: Pennsylvania
city: Beaufort
country: United States
facility: 24
state: South Carolina
city: Chattanooga
country: United States
facility: 114
state: Tennessee
city: Nashville
country: United States
facility: 1
state: Tennessee
city: Austin
country: United States
facility: 138
state: Texas
city: Dallas
country: United States
facility: 111
state: Texas
city: Dallas
country: United States
facility: 22
state: Texas
city: El Paso
country: United States
facility: 46
state: Texas
city: Houston
country: United States
facility: 51
state: Texas
city: Houston
country: United States
facility: 53
state: Texas
city: San Antonio
country: United States
facility: 98
state: Texas
city: Temple
country: United States
facility: 82
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: 16
state: Virginia
city: Richmond
country: United States
facility: 106
state: Virginia
city: Winchester
country: United States
facility: 125
state: Virginia
city: Renton
country: United States
facility: 74
state: Washington
city: Madison
country: United States
facility: 80
state: Wisconsin
city: Milwaukee
country: United States
facility: 28
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: Maroochydore
country: Australia
facility: 422
state: Queensland
city: Adelaide
country: Australia
facility: 420
state: South Australia
city: Clayton
country: Australia
facility: 429
state: Victoria
city: Parkville
country: Australia
facility: 427
state: Victoria
city: Innsbruck
country: Austria
facility: 204
city: Calgary
country: Canada
facility: 127
state: Alberta
city: Halifax
country: Canada
facility: 140
state: Nova Scotia
city: Hamilton
country: Canada
facility: 116
state: Ontario
city: London
country: Canada
facility: 93
state: Ontario
city: Greenfield Park
country: Canada
facility: 91
state: Quebec
city: Montreal
country: Canada
facility: 110
state: Quebec
city: Montreal
country: Canada
facility: 113
state: Quebec
city: Aarhus
country: Denmark
facility: 223
city: Copenhagen
country: Denmark
facility: 220
city: Bron
country: France
facility: 402
city: Dijon
country: France
facility: 404
city: Ramonville Saint Agne
country: France
facility: 405
city: Berlin
country: Germany
facility: 465
city: Mainz
country: Germany
facility: 461
city: Dublin
country: Ireland
facility: 240
city: Bologna
country: Italy
facility: 442
city: Catanzaro
country: Italy
facility: 449
city: Ferrara
country: Italy
facility: 443
city: Milano
country: Italy
facility: 441
city: Perugia
country: Italy
facility: 450
city: Pisa
country: Italy
facility: 448
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: 283
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: San Juan
country: Puerto Rico
facility: 158
city: Granada
country: Spain
facility: 323
city: Santa Cruz De Tenerife
country: Spain
facility: 324
city: Blackpool
country: United Kingdom
facility: 360
city: London
country: United Kingdom
facility: 364
city: London
country: United Kingdom
facility: 369
city: Manchester
country: United Kingdom
facility: 361
city: Middlesborough
country: United Kingdom
facility: 363
city: Stoke on Trent
country: United Kingdom
facility: 368
city: Truro
country: United Kingdom
facility: 367
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Wechsler RT, Li G, French J, O'Brien TJ, D'Cruz O, Williams P, Goodson R, Brock M; ALEX-MT Study Group. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014 Jul;55(7):1088-98. doi: 10.1111/epi.12681. Epub 2014 Jun 10.