Clinical trial NCT00955357: Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
Official title: An Open-Label, Multicenter, Multinational Study of Lacosamide as First Add-On Anti-epileptic Drug (AED) Treatment in Subjects With Partial-Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Partial Epilepsies
Keywords: Epilepsy Treatment
Anti-epileptic drugs
Seizures
Vimpat
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2009-08-10
Enrollment: 461
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

Detailed description: The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and Period 3: a 3-week Taper/Safety Follow-Up Phase.

Eligibility criteria: Inclusion Criteria:

Group 1:

* Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
* Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED) for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior use of rescue medication (short-term intermittent use) is acceptable
* Epilepsy diagnosis should be ≤24 months at the time of the Screening Visit
* The minimum allowed seizure frequency at any time during the 12 weeks prior to the Screening Visit is ≥3 partial-onset seizures

Group 2:

* Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
* Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens (concurrently or sequentially)
* Epilepsy diagnosis should be ≥5 years at the time of the Screening Visit
* The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit is ≥1 partial-onset seizure per 28 days

Exclusion Criteria:

* Previous use of Lacosamide
* History of seizure disorder characterized primarily by isolated auras
* History of primary generalized seizures
* History of status epilepticus within last 12-months
* History of cluster seizures during the 12 week period prior to Visit 1
* Nonepileptic events, including pseudoseizures that could be confused with seizure
* Lifetime history of suicide attempt or suicidal ideation in the past 6 months
* Hypersensitivity to any component of Lacosamide
* History of drug or alcohol abuse
* History of an acute or subacutely progressive Central Nervous System (CNS) disease
* Undergone cranial surgery within the last year prior to study entry
* Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6 months
* Prior or concomitant Vigabatrin use

Primary outcomes:
measure: The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase
timeFrame: From Week 7 (end of Week 6) to end of Week 18
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: 103
state: California
city: Rancho Mirage
country: United States
facility: 123
state: California
city: Clearwater
country: United States
facility: 156
state: Florida
city: Destin
country: United States
facility: 157
state: Florida
city: Hollywood
country: United States
facility: 140
state: Florida
city: Ocala
country: United States
facility: 161
state: Florida
city: Atlanta
country: United States
facility: 108
state: Georgia
city: Atlanta
country: United States
facility: 112
state: Georgia
city: Augusta
country: United States
facility: 124
state: Georgia
city: Macon
country: United States
facility: 115
state: Georgia
city: Rome
country: United States
facility: 118
state: Georgia
city: Flossmoor
country: United States
facility: 128
state: Illinois
city: Des Moines
country: United States
facility: 130
state: Iowa
city: Bowling Green
country: United States
facility: 102
state: Kentucky
city: Paducah
country: United States
facility: 117
state: Kentucky
city: Houma
country: United States
facility: 107
state: Louisiana
city: Ruston
country: United States
facility: 145
state: Louisiana
city: Annapolis
country: United States
facility: 101
state: Maryland
city: Waldorf
country: United States
facility: 162
state: Maryland
city: Boston
country: United States
facility: 153
state: Massachusetts
city: Pittsfield
country: United States
facility: 136
state: Massachusetts
city: Springfield
country: United States
facility: 144
state: Massachusetts
city: Kansas City
country: United States
facility: 151
state: Missouri
city: Paterson
country: United States
facility: 114
state: New Jersey
city: Brooklyn
country: United States
facility: 109
state: New York
city: Brooklyn
country: United States
facility: 133
state: New York
city: West Seneca
country: United States
facility: 127
state: New York
city: Charlotte
country: United States
facility: 158
state: North Carolina
city: Bismarck
country: United States
facility: 139
state: North Dakota
city: Akron
country: United States
facility: 134
state: Ohio
city: Canton
country: United States
facility: 150
state: Ohio
city: Tulsa
country: United States
facility: 141
state: Oklahoma
city: Indiana
country: United States
facility: 121
state: Pennsylvania
city: Columbia
country: United States
facility: 120
state: South Carolina
city: Orangeburg
country: United States
facility: 149
state: South Carolina
city: Spartanburg
country: United States
facility: 152
state: South Carolina
city: Austin
country: United States
facility: 148
state: Texas
city: Dallas
country: United States
facility: 154
state: Texas
city: Tomball
country: United States
facility: 146
state: Texas
city: Fredericksburg
country: United States
facility: 119
state: Virginia
city: Wien
country: Austria
facility: 503
city: Blagoevrad
country: Bulgaria
facility: 703
city: Pleven
country: Bulgaria
facility: 706
city: Sofia
country: Bulgaria
facility: 700
city: Sofia
country: Bulgaria
facility: 702
city: Sofia
country: Bulgaria
facility: 704
city: Sofia
country: Bulgaria
facility: 705
city: Sofia
country: Bulgaria
facility: 707
city: Sofia
country: Bulgaria
facility: 708
city: Varna
country: Bulgaria
facility: 701
city: Hradec Kralove
country: Czechia
facility: 736
city: Litomerice
country: Czechia
facility: 735
city: Ostrava-Hrabuvka
country: Czechia
facility: 732
city: Ostrava
country: Czechia
facility: 733
city: Praha 11
country: Czechia
facility: 737
city: Trutnov
country: Czechia
facility: 734
city: Aarhus
country: Denmark
facility: 930
city: Helsinki
country: Finland
facility: 400
city: Oulu
country: Finland
facility: 402
city: Tampere
country: Finland
facility: 401
city: Strasbourg
country: France
facility: 610
city: Toulon
country: France
facility: 611
city: Athens
country: Greece
facility: 521
city: Thessaloniki
country: Greece
facility: 520
city: Faenza
country: Italy
facility: 552
city: Gallarate
country: Italy
facility: 546
city: Napoli
country: Italy
facility: 541
city: Pietra Ligure
country: Italy
facility: 559
city: Prato
country: Italy
facility: 557
city: Roma
country: Italy
facility: 540
city: Roma
country: Italy
facility: 549
city: Taranto
country: Italy
facility: 542
city: Torino
country: Italy
facility: 547
city: Trieste
country: Italy
facility: 551
city: Aguascalientes
country: Mexico
facility: 180
city: Chihuahua
country: Mexico
facility: 183
city: Chihuahua
country: Mexico
facility: 185
city: Ciudad Juarez
country: Mexico
facility: 184
city: Guadalajara
country: Mexico
facility: 189
city: Mexico DF
country: Mexico
facility: 181
city: Mexico DF
country: Mexico
facility: 193
city: Mexico DF
country: Mexico
facility: 195
city: Monterrey
country: Mexico
facility: 186
city: Monterrey
country: Mexico
facility: 187
city: Monterrey
country: Mexico
facility: 188
city: Polanco
country: Mexico
facility: 182
city: Bucarest
country: Romania
facility: 815
city: Cluj-napoca
country: Romania
facility: 810
city: Oradea
country: Romania
facility: 814
city: Targu Mures
country: Romania
facility: 813
city: Kazan
country: Russian Federation
facility: 830
city: Kazan
country: Russian Federation
facility: 831
city: Moscow
country: Russian Federation
facility: 834
city: Novosibirsk
country: Russian Federation
facility: 833
city: Terrassa
country: Spain
facility: 598
state: Barcelona
city: Almeria
country: Spain
facility: 592
city: Bajo Sevilla
country: Spain
facility: 597
city: Barcelona
country: Spain
facility: 590
city: Santiago de Compostela
country: Spain
facility: 596
city: Valencia
country: Spain
facility: 594
city: Valladolid
country: Spain
facility: 599
city: Lausanne
country: Switzerland
facility: 892
city: Adana
country: Turkey
facility: 713
city: Ankara
country: Turkey
facility: 714
city: Eskisehir
country: Turkey
facility: 710
city: Istanbul
country: Turkey
facility: 711
city: Istanbul
country: Turkey
facility: 719
city: Izmir
country: Turkey
facility: 717
city: Trabzon
country: Turkey
facility: 718
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: