A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
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
2 other identifiers
interventional
540
33 countries
139
Brief Summary
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2014
Longer than P75 for phase_3
139 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2013
CompletedFirst Posted
Study publicly available on registry
October 17, 2013
CompletedStudy Start
First participant enrolled
August 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2022
CompletedResults Posted
Study results publicly available
October 25, 2022
CompletedOctober 25, 2022
September 1, 2022
7.7 years
October 14, 2013
September 30, 2022
September 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
From Week 0 to the End of Safety Follow-Up (up to Week 104)
Percentage of Participants With Serious TEAEs
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.
From Week 0 to the End of Safety Follow-Up (up to Week 104)
Percentage of Participants With TEAEs Leading to Study Discontinuation
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.
From Week 0 to the End of Safety Follow-Up (up to Week 104)
Secondary Outcomes (1)
Percentage of Seizure-free Days During the Study
From Week 0 to End of Treatment (up to Week 96)
Study Arms (1)
Lacosamide
EXPERIMENTALIn 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.
Interventions
Pharmaceutical form: oral solution Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day) Route of administration: oral use
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB BIOSCIENCES, Inc.lead
- UCB Biopharma SRLcollaborator
Study Sites (141)
Ep0034 638
Birmingham, Alabama, 35233-1711, United States
Ep0034 105
Orlando, Florida, 32819, United States
Ep0034 117
Tampa, Florida, 33609, United States
Ep0034 124
Lexington, Kentucky, 40536-0284, United States
Ep0034 115
Henderson, Nevada, 89052, United States
Ep0034 120
Lebanon, New Hampshire, 03756, United States
Ep0034 102
Charlotte, North Carolina, 28203, United States
Ep0034 640
Springfield, Oregon, 97477, United States
Ep0034 129
Dallas, Texas, 75235, United States
Ep0034 630
San Antonio, Texas, 78207, United States
Ep0034 114
Seattle, Washington, 98105-0371, United States
Ep0034 143
Ciudad Autonoma de Buenos AIRE, Argentina
Ep0034 142
Córdoba, Argentina
Ep0034 200
Melbourne, Australia
Ep0034 203
Parkville, Australia
Ep0034 205
South Brisbane, Australia
Ep0034 304
Brussels, Belgium
Ep0034 158
Passo Fundo, Brazil
Ep0034 150
São Paulo, Brazil
Ep0034 154
São Paulo, Brazil
Ep0034 310
Plovdiv, Bulgaria
Ep0034 530
Beijing, China
Ep0034 535
Changchun, China
Ep0034 532
Chongqing, China
Ep0034 536
Nanchang, China
Ep0034 531
Shanghai, China
Ep0034 537
Shenzhen, China
Ep0034 171
Medellín, Colombia
Ep0034 613
Osijek, Croatia
Ep0034 610
Rijeka, Croatia
Ep0034 612
Zagreb, Croatia
Ep0034 321
Hradec Králové, Czechia
Ep0034 320
Ostrava-poruba, Czechia
Ep0034 323
Prague, Czechia
Ep0034 322
Praha 4 - KRC, Czechia
Ep0034 331
Tallinn, Estonia
Ep0034 330
Tartu, Estonia
Ep0034 346
Rennes, France
Ep0034 344
Strasbourg, France
Ep0034 620
Tbilisi, Georgia
Ep0034 621
Tbilisi, Georgia
Ep0034 622
Tbilisi, Georgia
Ep0034 623
Tbilisi, Georgia
Ep0034 542
Athens, Greece
Ep0034 361
Budapest, Hungary
Ep0034 362
Budapest, Hungary
Ep0034 363
Budapest, Hungary
Ep0034 364
Budapest, Hungary
Ep0034 368
Budapest, Hungary
Ep0034 360
Debrecen, Hungary
Ep0034 367
Miskolc, Hungary
Ep0034 366
Pécs, Hungary
Ep0034 374
Petah Tikva, Israel
Ep0034 397
Genova, Italy
Ep0034 380
Mantova, Italy
Ep0034 398
Messina, Italy
Ep0034 381
Milan, Italy
Ep0034 393
Padua, Italy
Ep0034 383
Roma, Italy
Ep0034 392
Roma, Italy
Ep0034 395
Roma, Italy
Ep0034 386
Verona, Italy
Ep0034 400
Riga, Latvia
Ep0034 402
Valmiera, Latvia
Ep0034 411
Kaunas, Lithuania
Ep0034 694
Aguascalientes, Mexico
Ep0034 569
Culiacán, Mexico
Ep0034 693
Culiacán, Mexico
Ep0034 563
Guadalajara, Mexico
Ep0034 564
México, Mexico
Ep0034 568
Monterrey, Mexico
Ep0034 650
Chisinau, Moldova
Ep0034 660
Podgorica, Montenegro
Ep0034 724
Cebu, Philippines
Ep0034 721
Manila, Philippines
Ep0034 433
Gdansk, Poland
Ep0034 420
Kielce, Poland
Ep0034 422
Krakow, Poland
Ep0034 431
Krakow, Poland
Ep0034 423
Poznan, Poland
Ep0034 425
Poznan, Poland
Ep0034 429
Tyniec Mały, Poland
Ep0034 430
Warsaw, Poland
Ep0034 428
Wroclaw, Poland
Ep0034 750
Lisbon, Portugal
Ep0034 574
Bucharest, Romania
Ep0034 581
Bucharest, Romania
Ep0034 572
Cluj-Napoca, Romania
Ep0034 582
Iași, Romania
Ep0034 573
Sibiu, Romania
Ep0034 576
Sibiu, Romania
Ep0034 580
Suceava, Romania
Ep0034 570
Timișoara, Romania
Ep0034 577
Timișoara, Romania
Ep0034 443
Kazan', Russia
Ep0034 444
Kazan', Russia
Ep0034 454
Kemerovo, Russia
Ep0034 442
Moscow, Russia
Ep0034 449
Moscow, Russia
Ep0034 456
Nizhny Novgorod, Russia
Ep0034 452
Novosibirsk, Russia
Ep0034 453
Omsk, Russia
Ep0034 455
Perm, Russia
Ep0034 441
Saint Petersburg, Russia
Ep0034 446
Saint Petersburg, Russia
Ep0034 440
Smolensk, Russia
Ep0034 730
Smolensk, Russia
Ep0034 458
Tomsk, Russia
Ep0034 447
Voronezh, Russia
Ep0034 450
Yekaterinburg, Russia
Ep0034 461
Belgrade, Serbia
Ep0034 464
Belgrade, Serbia
Ep0034 460
Kragujevac, Serbia
Ep0034 462
Novi Sad, Serbia
Ep0034 463
Novi Sad, Serbia
Ep0034 470
Bardejov, Slovakia
Ep0034 472
Nové Zámky, Slovakia
Ep0034 670
Ljubljana, Slovenia
Ep0034 211
Daegu, South Korea
Ep0034 210
Seoul, South Korea
Ep0034 212
Seoul, South Korea
Ep0034 213
Seoul, South Korea
Ep0034 215
Seoul, South Korea
Ep0034 220
Changhua, Taiwan
Ep0034 222
Taichung, Taiwan
Ep0034 224
Taipei, Taiwan
Ep0034 236
Bangkoknoi, Thailand
Ep0034 235
Pathum Wan, Thailand
Ep0034 230
Ratchathewi, Thailand
Ep0034 232
Ratchathewi, Thailand
Ep0034 231
Tha Muang, Thailand
Ep0034 233
Tha Muang, Thailand
Ep0034 602
Dnipro, Ukraine
Ep0034 609
Dnipro, Ukraine
Ep0034 681
Ivano-Frankivsk, Ukraine
Ep0034 600
Kiev, Ukraine
Ep0034 606
Kiev, Ukraine
Ep0034 682
Uzhhorod, Ukraine
Ep0034 603
Vinnytsia, Ukraine
Ep0034 515
Cambridge, United Kingdom
Ep0034 511
Leeds, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 14, 2013
First Posted
October 17, 2013
Study Start
August 13, 2014
Primary Completion
April 13, 2022
Study Completion
April 13, 2022
Last Updated
October 25, 2022
Results First Posted
October 25, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.