Clinical trial NCT01964560: A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
Official title: A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Lacosamide
Vimpat
UCB
Epilepsy
Partial-Onset Seizures
Pediatric
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: UCB Biopharma SRL
First posted: 2013-10-17
Enrollment: 540
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.


Eligibility criteria: Inclusion Criteria:

* An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
* Subject has completed the Transition Period of SP0967 \[NCT02477839\] or SP0969 \[NCT01921205\] for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy
* Subject is expected to benefit from participation, in the opinion of the investigator
* Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator
* Subject is male or female aged 1 month to ≤17 years
* Subject has a diagnosis of epilepsy with partial-onset seizures

Exclusion Criteria:

* Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
* Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE)
* For subjects ≥6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1
* Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Week 0 to the End of Safety Follow-Up (up to Week 104)
measure: Percentage of Participants With Serious TEAEs
timeFrame: From Week 0 to the End of Safety Follow-Up (up to Week 104)
measure: Percentage of Participants With TEAEs Leading to Study Discontinuation
timeFrame: From Week 0 to the End of Safety Follow-Up (up to Week 104)
Secondary outcomes:
measure: Percentage of Seizure-free Days During the Study
timeFrame: From Week 0 to End of Treatment (up to Week 96)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ep0034 638
state: Alabama
city: Orlando
country: United States
facility: Ep0034 105
state: Florida
city: Tampa
country: United States
facility: Ep0034 117
state: Florida
city: Lexington
country: United States
facility: Ep0034 124
state: Kentucky
city: Henderson
country: United States
facility: Ep0034 115
state: Nevada
city: Lebanon
country: United States
facility: Ep0034 120
state: New Hampshire
city: Charlotte
country: United States
facility: Ep0034 102
state: North Carolina
city: Springfield
country: United States
facility: Ep0034 640
state: Oregon
city: Dallas
country: United States
facility: Ep0034 129
state: Texas
city: San Antonio
country: United States
facility: Ep0034 630
state: Texas
city: Seattle
country: United States
facility: Ep0034 114
state: Washington
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Ep0034 143
city: Cordoba
country: Argentina
facility: Ep0034 142
city: Melbourne
country: Australia
facility: Ep0034 200
city: Parkville
country: Australia
facility: Ep0034 203
city: South Brisbane
country: Australia
facility: Ep0034 205
city: Brussels
country: Belgium
facility: Ep0034 304
city: Passo Fundo
country: Brazil
facility: Ep0034 158
city: Sao Paulo
country: Brazil
facility: Ep0034 150
city: Sao Paulo
country: Brazil
facility: Ep0034 154
city: Plovdiv
country: Bulgaria
facility: Ep0034 310
city: Beijing
country: China
facility: Ep0034 530
city: Changchun
country: China
facility: Ep0034 535
city: Chongqing
country: China
facility: Ep0034 532
city: Nanchang
country: China
facility: Ep0034 536
city: Shanghai
country: China
facility: Ep0034 531
city: Shenzhen
country: China
facility: Ep0034 537
city: Medellin
country: Colombia
facility: Ep0034 171
city: Osijek
country: Croatia
facility: Ep0034 613
city: Rijeka
country: Croatia
facility: Ep0034 610
city: Zagreb
country: Croatia
facility: Ep0034 612
city: Hradec Kralove
country: Czechia
facility: Ep0034 321
city: Ostrava-poruba
country: Czechia
facility: Ep0034 320
city: Praha 4 - Krc
country: Czechia
facility: Ep0034 322
city: Praha 5
country: Czechia
facility: Ep0034 323
city: Tallinn
country: Estonia
facility: Ep0034 331
city: Tartu
country: Estonia
facility: Ep0034 330
city: Rennes Cedex 2
country: France
facility: Ep0034 346
city: Strasbourg Cedex
country: France
facility: Ep0034 344
city: Tbilisi
country: Georgia
facility: Ep0034 620
city: Tbilisi
country: Georgia
facility: Ep0034 621
city: Tbilisi
country: Georgia
facility: Ep0034 622
city: Tbilisi
country: Georgia
facility: Ep0034 623
city: Athens
country: Greece
facility: Ep0034 542
city: Budapest
country: Hungary
facility: Ep0034 361
city: Budapest
country: Hungary
facility: Ep0034 362
city: Budapest
country: Hungary
facility: Ep0034 363
city: Budapest
country: Hungary
facility: Ep0034 364
city: Budapest
country: Hungary
facility: Ep0034 368
city: Debrecen
country: Hungary
facility: Ep0034 360
city: Miskolc
country: Hungary
facility: Ep0034 367
city: Pecs
country: Hungary
facility: Ep0034 366
city: Petah Tiqwa
country: Israel
facility: Ep0034 374
city: Genova
country: Italy
facility: Ep0034 397
city: Mantova
country: Italy
facility: Ep0034 380
city: Messina
country: Italy
facility: Ep0034 398
city: Milano
country: Italy
facility: Ep0034 381
city: Padova
country: Italy
facility: Ep0034 393
city: Roma
country: Italy
facility: Ep0034 383
city: Roma
country: Italy
facility: Ep0034 392
city: Roma
country: Italy
facility: Ep0034 395
city: Verona
country: Italy
facility: Ep0034 386
city: Daegu
country: Korea, Republic of
facility: Ep0034 211
city: Seoul
country: Korea, Republic of
facility: Ep0034 210
city: Seoul
country: Korea, Republic of
facility: Ep0034 212
city: Seoul
country: Korea, Republic of
facility: Ep0034 213
city: Seoul
country: Korea, Republic of
facility: Ep0034 215
city: Riga
country: Latvia
facility: Ep0034 400
city: Valmiera
country: Latvia
facility: Ep0034 402
city: Kaunas
country: Lithuania
facility: Ep0034 411
city: Aguascalientes
country: Mexico
facility: Ep0034 694
city: Culiacan
country: Mexico
facility: Ep0034 569
city: Culiacan
country: Mexico
facility: Ep0034 693
city: Guadalajara
country: Mexico
facility: Ep0034 563
city: Mexico
country: Mexico
facility: Ep0034 564
city: Monterrey
country: Mexico
facility: Ep0034 568
city: Chisinau
country: Moldova, Republic of
facility: Ep0034 650
city: Podgorica
country: Montenegro
facility: Ep0034 660
city: Cebu
country: Philippines
facility: Ep0034 724
city: Manila
country: Philippines
facility: Ep0034 721
city: Gdansk
country: Poland
facility: Ep0034 433
city: Kielce
country: Poland
facility: Ep0034 420
city: Krakow
country: Poland
facility: Ep0034 422
city: Krakow
country: Poland
facility: Ep0034 431
city: Poznan
country: Poland
facility: Ep0034 423
city: Poznan
country: Poland
facility: Ep0034 425
city: Tyniec Maly
country: Poland
facility: Ep0034 429
city: Warszawa
country: Poland
facility: Ep0034 430
city: Wroclaw
country: Poland
facility: Ep0034 428
city: Lisbon
country: Portugal
facility: Ep0034 750
city: Bucuresti
country: Romania
facility: Ep0034 574
city: Bucuresti
country: Romania
facility: Ep0034 581
city: Cluj-napoca
country: Romania
facility: Ep0034 572
city: Iasi
country: Romania
facility: Ep0034 582
city: Sibiu
country: Romania
facility: Ep0034 573
city: Sibiu
country: Romania
facility: Ep0034 576
city: Suceava
country: Romania
facility: Ep0034 580
city: Timisoara
country: Romania
facility: Ep0034 570
city: Timisoara
country: Romania
facility: Ep0034 577
city: Ekaterinburg
country: Russian Federation
facility: Ep0034 450
city: Kazan
country: Russian Federation
facility: Ep0034 443
city: Kazan
country: Russian Federation
facility: Ep0034 444
city: Kemerovo
country: Russian Federation
facility: Ep0034 454
city: Moscow
country: Russian Federation
facility: Ep0034 442
city: Moscow
country: Russian Federation
facility: Ep0034 449
city: Nizhniy Novgorod
country: Russian Federation
facility: Ep0034 456
city: Novosibirsk
country: Russian Federation
facility: Ep0034 452
city: Omsk
country: Russian Federation
facility: Ep0034 453
city: Perm
country: Russian Federation
facility: Ep0034 455
city: Saint Petersburg
country: Russian Federation
facility: Ep0034 441
city: Smolensk
country: Russian Federation
facility: Ep0034 440
city: Smolensk
country: Russian Federation
facility: Ep0034 730
city: St. Petersburg
country: Russian Federation
facility: Ep0034 446
city: Tomsk
country: Russian Federation
facility: Ep0034 458
city: Voronezh
country: Russian Federation
facility: Ep0034 447
city: Belgrade
country: Serbia
facility: Ep0034 461
city: Belgrade
country: Serbia
facility: Ep0034 464
city: Kragujevac
country: Serbia
facility: Ep0034 460
city: Novi Sad
country: Serbia
facility: Ep0034 462
city: Novi Sad
country: Serbia
facility: Ep0034 463
city: Bardejov
country: Slovakia
facility: Ep0034 470
city: Nove Zamky
country: Slovakia
facility: Ep0034 472
city: Ljubljana
country: Slovenia
facility: Ep0034 670
city: Changhua City
country: Taiwan
facility: Ep0034 220
city: Taichung
country: Taiwan
facility: Ep0034 222
city: Taipei
country: Taiwan
facility: Ep0034 224
city: Bangkoknoi
country: Thailand
facility: Ep0034 236
city: Pathum Wan
country: Thailand
facility: Ep0034 235
city: Ratchathewi
country: Thailand
facility: Ep0034 230
city: Ratchathewi
country: Thailand
facility: Ep0034 232
city: Tha Muang
country: Thailand
facility: Ep0034 231
city: Tha Muang
country: Thailand
facility: Ep0034 233
city: Dnipro
country: Ukraine
facility: Ep0034 602
city: Dnipro
country: Ukraine
facility: Ep0034 609
city: Ivano-frankivsk
country: Ukraine
facility: Ep0034 681
city: Kiev
country: Ukraine
facility: Ep0034 600
city: Kiev
country: Ukraine
facility: Ep0034 606
city: Uzhgorod
country: Ukraine
facility: Ep0034 682
city: Vinnytsia
country: Ukraine
facility: Ep0034 603
city: Cambridge
country: United Kingdom
facility: Ep0034 515
city: Leeds
country: United Kingdom
facility: Ep0034 511
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: