A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
- Registration Number
- NCT01964560
- Lead Sponsor
- UCB BIOSCIENCES, Inc.
- Brief Summary
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 540
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lacosamide Lacosamide In the first week after enrollment into EP0034 subjects will be dosed according to their weight: * Lacosamide (LCM) 10 mg/kg/day (oral solution) for subjects weighing \<30 kg * LCM 6 mg/kg/day (oral solution) for subjects weighing ≥30 kg to \<50 kg * LCM 300 mg/day (tablets) for subjects weighing ≥50 kg After 1 week the investigator may adjust the LCM dose during the Treatment Period based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) From Week 0 to the End of Safety Follow-Up (up to Week 104) An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Percentage of Participants With Serious TEAEs From Week 0 to the End of Safety Follow-Up (up to Week 104) A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Percentage of Participants With TEAEs Leading to Study Discontinuation From Week 0 to the End of Safety Follow-Up (up to Week 104) An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
- Secondary Outcome Measures
Name Time Method Percentage of Seizure-free Days During the Study From Week 0 to End of Treatment (up to Week 96) The number of seizure-free days was the total number of days within an interval for which daily diary data were available and no seizures were reported. The percentage of seizure-free days was computed as 100 times the number of seizure-free days in the interval divided by the number of days in the interval for which daily diary data were available. Percentage of seizure-free days was measured using data obtained from participant diaries from EP0034 and is presented for the overall Treatment only.
Trial Locations
- Locations (141)
Ep0034 431
🇵🇱Krakow, Poland
Ep0034 422
🇵🇱Krakow, Poland
Ep0034 433
🇵🇱Gdansk, Poland
Ep0034 425
🇵🇱Poznan, Poland
Ep0034 430
🇵🇱Warszawa, Poland
Ep0034 602
🇺🇦Dnipro, Ukraine
Ep0034 609
🇺🇦Dnipro, Ukraine
Ep0034 129
🇺🇸Dallas, Texas, United States
Ep0034 124
🇺🇸Lexington, Kentucky, United States
Ep0034 150
🇧🇷Sao Paulo, Brazil
Ep0034 120
🇺🇸Lebanon, New Hampshire, United States
Ep0034 115
🇺🇸Henderson, Nevada, United States
Ep0034 117
🇺🇸Tampa, Florida, United States
Ep0034 142
🇦🇷Cordoba, Argentina
Ep0034 582
🇷🇴Iasi, Romania
Ep0034 682
🇺🇦Uzhgorod, Ukraine
Ep0034 362
🇭🇺Budapest, Hungary
Ep0034 364
🇭🇺Budapest, Hungary
Ep0034 750
🇵🇹Lisbon, Portugal
Ep0034 446
🇷🇺St. Petersburg, Russian Federation
Ep0034 442
🇷🇺Moscow, Russian Federation
Ep0034 576
🇷🇴Sibiu, Romania
Ep0034 429
🇵🇱Tyniec Maly, Poland
Ep0034 428
🇵🇱Wroclaw, Poland
Ep0034 681
🇺🇦Ivano-frankivsk, Ukraine
Ep0034 450
🇷🇺Ekaterinburg, Russian Federation
Ep0034 444
🇷🇺Kazan, Russian Federation
Ep0034 453
🇷🇺Omsk, Russian Federation
Ep0034 511
🇬🇧Leeds, United Kingdom
Ep0034 581
🇷🇴Bucuresti, Romania
Ep0034 572
🇷🇴Cluj-napoca, Romania
Ep0034 622
🇬🇪Tbilisi, Georgia
Ep0034 574
🇷🇴Bucuresti, Romania
Ep0034 573
🇷🇴Sibiu, Romania
Ep0034 411
🇱🇹Kaunas, Lithuania
Ep0034 569
🇲🇽Culiacan, Mexico
Ep0034 693
🇲🇽Culiacan, Mexico
Ep0034 621
🇬🇪Tbilisi, Georgia
Ep0034 470
🇸🇰Bardejov, Slovakia
Ep0034 224
🇨🇳Taipei, Taiwan
Ep0034 171
🇨🇴Medellin, Colombia
Ep0034 564
🇲🇽Mexico, Mexico
Ep0034 670
🇸🇮Ljubljana, Slovenia
Ep0034 568
🇲🇽Monterrey, Mexico
Ep0034 650
🇲🇩Chisinau, Moldova, Republic of
Ep0034 463
🇷🇸Novi Sad, Serbia
Ep0034 580
🇷🇴Suceava, Romania
Ep0034 577
🇷🇴Timisoara, Romania
Ep0034 461
🇷🇸Belgrade, Serbia
Ep0034 230
🇹🇭Ratchathewi, Thailand
Ep0034 570
🇷🇴Timisoara, Romania
Ep0034 460
🇷🇸Kragujevac, Serbia
Ep0034 472
🇸🇰Nove Zamky, Slovakia
Ep0034 220
🇨🇳Changhua City, Taiwan
Ep0034 231
🇹🇭Tha Muang, Thailand
Ep0034 233
🇹🇭Tha Muang, Thailand
Ep0034 235
🇹🇭Pathum Wan, Thailand
Ep0034 346
🇫🇷Rennes Cedex 2, France
Ep0034 458
🇷🇺Tomsk, Russian Federation
Ep0034 447
🇷🇺Voronezh, Russian Federation
Ep0034 638
🇺🇸Birmingham, Alabama, United States
Ep0034 105
🇺🇸Orlando, Florida, United States
Ep0034 102
🇺🇸Charlotte, North Carolina, United States
Ep0034 640
🇺🇸Springfield, Oregon, United States
Ep0034 143
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Ep0034 630
🇺🇸San Antonio, Texas, United States
Ep0034 114
🇺🇸Seattle, Washington, United States
Ep0034 200
🇦🇺Melbourne, Australia
Ep0034 203
🇦🇺Parkville, Australia
Ep0034 304
🇧🇪Brussels, Belgium
Ep0034 205
🇦🇺South Brisbane, Australia
Ep0034 158
🇧🇷Passo Fundo, Brazil
Ep0034 154
🇧🇷Sao Paulo, Brazil
Ep0034 530
🇨🇳Beijing, China
Ep0034 535
🇨🇳Changchun, China
Ep0034 310
🇧🇬Plovdiv, Bulgaria
Ep0034 532
🇨🇳Chongqing, China
Ep0034 536
🇨🇳Nanchang, China
Ep0034 531
🇨🇳Shanghai, China
Ep0034 537
🇨🇳Shenzhen, China
Ep0034 322
🇨🇿Praha 4 - Krc, Czechia
Ep0034 610
🇭🇷Rijeka, Croatia
Ep0034 320
🇨🇿Ostrava-poruba, Czechia
Ep0034 612
🇭🇷Zagreb, Croatia
Ep0034 321
🇨🇿Hradec Kralove, Czechia
Ep0034 331
🇪🇪Tallinn, Estonia
Ep0034 323
🇨🇿Praha 5, Czechia
Ep0034 330
🇪🇪Tartu, Estonia
Ep0034 620
🇬🇪Tbilisi, Georgia
Ep0034 344
🇫🇷Strasbourg Cedex, France
Ep0034 363
🇭🇺Budapest, Hungary
Ep0034 542
🇬🇷Athens, Greece
Ep0034 623
🇬🇪Tbilisi, Georgia
Ep0034 361
🇭🇺Budapest, Hungary
Ep0034 368
🇭🇺Budapest, Hungary
Ep0034 366
🇭🇺Pecs, Hungary
Ep0034 360
🇭🇺Debrecen, Hungary
Ep0034 367
🇭🇺Miskolc, Hungary
Ep0034 397
🇮🇹Genova, Italy
Ep0034 398
🇮🇹Messina, Italy
Ep0034 374
🇮🇱Petah Tiqwa, Israel
Ep0034 380
🇮🇹Mantova, Italy
Ep0034 381
🇮🇹Milano, Italy
Ep0034 402
🇱🇻Valmiera, Latvia
Ep0034 393
🇮🇹Padova, Italy
Ep0034 392
🇮🇹Roma, Italy
Ep0034 395
🇮🇹Roma, Italy
Ep0034 383
🇮🇹Roma, Italy
Ep0034 386
🇮🇹Verona, Italy
Ep0034 400
🇱🇻Riga, Latvia
Ep0034 694
🇲🇽Aguascalientes, Mexico
Ep0034 563
🇲🇽Guadalajara, Mexico
Ep0034 660
🇲🇪Podgorica, Montenegro
Ep0034 721
🇵🇭Manila, Philippines
Ep0034 724
🇵🇭Cebu, Philippines
Ep0034 420
🇵🇱Kielce, Poland
Ep0034 423
🇵🇱Poznan, Poland
Ep0034 454
🇷🇺Kemerovo, Russian Federation
Ep0034 443
🇷🇺Kazan, Russian Federation
Ep0034 449
🇷🇺Moscow, Russian Federation
Ep0034 456
🇷🇺Nizhniy Novgorod, Russian Federation
Ep0034 440
🇷🇺Smolensk, Russian Federation
Ep0034 452
🇷🇺Novosibirsk, Russian Federation
Ep0034 441
🇷🇺Saint Petersburg, Russian Federation
Ep0034 455
🇷🇺Perm, Russian Federation
Ep0034 730
🇷🇺Smolensk, Russian Federation
Ep0034 462
🇷🇸Novi Sad, Serbia
Ep0034 464
🇷🇸Belgrade, Serbia
Ep0034 222
🇨🇳Taichung, Taiwan
Ep0034 232
🇹🇭Ratchathewi, Thailand
Ep0034 236
🇹🇭Bangkoknoi, Thailand
Ep0034 606
🇺🇦Kiev, Ukraine
Ep0034 600
🇺🇦Kiev, Ukraine
Ep0034 603
🇺🇦Vinnytsia, Ukraine
Ep0034 211
🇰🇷Daegu, Korea, Republic of
Ep0034 210
🇰🇷Seoul, Korea, Republic of
Ep0034 213
🇰🇷Seoul, Korea, Republic of
Ep0034 215
🇰🇷Seoul, Korea, Republic of
Ep0034 515
🇬🇧Cambridge, United Kingdom
Ep0034 212
🇰🇷Seoul, Korea, Republic of
Ep0034 613
🇭🇷Osijek, Croatia