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

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

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Lacosamide; Drug: Lacosamide

• Study Type: Interventional
• Enrollment (Actual): 540
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina
    • Ep0034 143
  • Cordoba, Argentina
    • Ep0034 142
• Australia
  • Melbourne, Australia
    • Ep0034 200
  • Parkville, Australia
    • Ep0034 203
  • South Brisbane, Australia
    • Ep0034 205
• Belgium
  • Brussels, Belgium
    • Ep0034 304
• Brazil
  • Passo Fundo, Brazil
    • Ep0034 158
  • Sao Paulo, Brazil
    • Ep0034 150
  • Sao Paulo, Brazil
    • Ep0034 154
• Bulgaria
  • Plovdiv, Bulgaria
    • Ep0034 310
• China
  • Beijing, China
    • Ep0034 530
  • Changchun, China
    • Ep0034 535
  • Chongqing, China
    • Ep0034 532
  • Nanchang, China
    • Ep0034 536
  • Shanghai, China
    • Ep0034 531
  • Shenzhen, China
    • Ep0034 537
• Colombia
  • Medellin, Colombia
    • Ep0034 171
• Croatia
  • Osijek, Croatia
    • Ep0034 613
  • Rijeka, Croatia
    • Ep0034 610
  • Zagreb, Croatia
    • Ep0034 612
• Czechia
  • Hradec Kralove, Czechia
    • Ep0034 321
  • Ostrava-poruba, Czechia
    • Ep0034 320
  • Praha 4 - Krc, Czechia
    • Ep0034 322
  • Praha 5, Czechia
    • Ep0034 323
• Estonia
  • Tallinn, Estonia
    • Ep0034 331
  • Tartu, Estonia
    • Ep0034 330
• France
  • Rennes Cedex 2, France
    • Ep0034 346
  • Strasbourg Cedex, France
    • Ep0034 344
• Georgia
  • Tbilisi, Georgia
    • Ep0034 620
  • Tbilisi, Georgia
    • Ep0034 621
  • Tbilisi, Georgia
    • Ep0034 622
  • Tbilisi, Georgia
    • Ep0034 623
• Greece
  • Athens, Greece
    • Ep0034 542
• Hungary
  • Budapest, Hungary
    • Ep0034 361
  • Budapest, Hungary
    • Ep0034 362
  • Budapest, Hungary
    • Ep0034 363
  • Budapest, Hungary
    • Ep0034 364
  • Budapest, Hungary
    • Ep0034 368
  • Debrecen, Hungary
    • Ep0034 360
  • Miskolc, Hungary
    • Ep0034 367
  • Pecs, Hungary
    • Ep0034 366
• Israel
  • Petah Tiqwa, Israel
    • Ep0034 374
• Italy
  • Genova, Italy
    • Ep0034 397
  • Mantova, Italy
    • Ep0034 380
  • Messina, Italy
    • Ep0034 398
  • Milano, Italy
    • Ep0034 381
  • Padova, Italy
    • Ep0034 393
  • Roma, Italy
    • Ep0034 383
  • Roma, Italy
    • Ep0034 392
  • Roma, Italy
    • Ep0034 395
  • Verona, Italy
    • Ep0034 386
• Korea, Republic of
  • Daegu, Korea, Republic of
    • Ep0034 211
  • Seoul, Korea, Republic of
    • Ep0034 210
  • Seoul, Korea, Republic of
    • Ep0034 212
  • Seoul, Korea, Republic of
    • Ep0034 213
  • Seoul, Korea, Republic of
    • Ep0034 215
• Latvia
  • Riga, Latvia
    • Ep0034 400
  • Valmiera, Latvia
    • Ep0034 402
• Lithuania
  • Kaunas, Lithuania
    • Ep0034 411
• Mexico
  • Aguascalientes, Mexico
    • Ep0034 694
  • Culiacan, Mexico
    • Ep0034 569
  • Culiacan, Mexico
    • Ep0034 693
  • Guadalajara, Mexico
    • Ep0034 563
  • Mexico, Mexico
    • Ep0034 564
  • Monterrey, Mexico
    • Ep0034 568
• Moldova, Republic of
  • Chisinau, Moldova, Republic of
    • Ep0034 650
• Montenegro
  • Podgorica, Montenegro
    • Ep0034 660
• Philippines
  • Cebu, Philippines
    • Ep0034 724
  • Manila, Philippines
    • Ep0034 721
• Poland
  • Gdansk, Poland
    • Ep0034 433
  • Kielce, Poland
    • Ep0034 420
  • Krakow, Poland
    • Ep0034 422
  • Krakow, Poland
    • Ep0034 431
  • Poznan, Poland
    • Ep0034 423
  • Poznan, Poland
    • Ep0034 425
  • Tyniec Maly, Poland
    • Ep0034 429
  • Warszawa, Poland
    • Ep0034 430
  • Wroclaw, Poland
    • Ep0034 428
• Portugal
  • Lisbon, Portugal
    • Ep0034 750
• Romania
  • Bucuresti, Romania
    • Ep0034 574
  • Bucuresti, Romania
    • Ep0034 581
  • Cluj-napoca, Romania
    • Ep0034 572
  • Iasi, Romania
    • Ep0034 582
  • Sibiu, Romania
    • Ep0034 573
  • Sibiu, Romania
    • Ep0034 576
  • Suceava, Romania
    • Ep0034 580
  • Timisoara, Romania
    • Ep0034 570
  • Timisoara, Romania
    • Ep0034 577
• Russian Federation
  • Ekaterinburg, Russian Federation
    • Ep0034 450
  • Kazan, Russian Federation
    • Ep0034 443
  • Kazan, Russian Federation
    • Ep0034 444
  • Kemerovo, Russian Federation
    • Ep0034 454
  • Moscow, Russian Federation
    • Ep0034 442
  • Moscow, Russian Federation
    • Ep0034 449
  • Nizhniy Novgorod, Russian Federation
    • Ep0034 456
  • Novosibirsk, Russian Federation
    • Ep0034 452
  • Omsk, Russian Federation
    • Ep0034 453
  • Perm, Russian Federation
    • Ep0034 455
  • Saint Petersburg, Russian Federation
    • Ep0034 441
  • Smolensk, Russian Federation
    • Ep0034 440
  • Smolensk, Russian Federation
    • Ep0034 730
  • St. Petersburg, Russian Federation
    • Ep0034 446
  • Tomsk, Russian Federation
    • Ep0034 458
  • Voronezh, Russian Federation
    • Ep0034 447
• Serbia
  • Belgrade, Serbia
    • Ep0034 461
  • Belgrade, Serbia
    • Ep0034 464
  • Kragujevac, Serbia
    • Ep0034 460
  • Novi Sad, Serbia
    • Ep0034 462
  • Novi Sad, Serbia
    • Ep0034 463
• Slovakia
  • Bardejov, Slovakia
    • Ep0034 470
  • Nove Zamky, Slovakia
    • Ep0034 472
• Slovenia
  • Ljubljana, Slovenia
    • Ep0034 670
• Taiwan
  • Changhua City, Taiwan
    • Ep0034 220
  • Taichung, Taiwan
    • Ep0034 222
  • Taipei, Taiwan
    • Ep0034 224
• Thailand
  • Bangkoknoi, Thailand
    • Ep0034 236
  • Pathum Wan, Thailand
    • Ep0034 235
  • Ratchathewi, Thailand
    • Ep0034 230
  • Ratchathewi, Thailand
    • Ep0034 232
  • Tha Muang, Thailand
    • Ep0034 231
  • Tha Muang, Thailand
    • Ep0034 233
• Ukraine
  • Dnipro, Ukraine
    • Ep0034 602
  • Dnipro, Ukraine
    • Ep0034 609
  • Ivano-frankivsk, Ukraine
    • Ep0034 681
  • Kiev, Ukraine
    • Ep0034 600
  • Kiev, Ukraine
    • Ep0034 606
  • Uzhgorod, Ukraine
    • Ep0034 682
  • Vinnytsia, Ukraine
    • Ep0034 603
• United Kingdom
  • Cambridge, United Kingdom
    • Ep0034 515
  • Leeds, United Kingdom
    • Ep0034 511
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1711
      • Ep0034 638
  • Florida
    • Orlando, Florida, United States, 32819
      • Ep0034 105
    • Tampa, Florida, United States, 33609
      • Ep0034 117
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0284
      • Ep0034 124
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Ep0034 115
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Ep0034 120
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Ep0034 102
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Ep0034 640
  • Texas
    • Dallas, Texas, United States, 75235
      • Ep0034 129
    • San Antonio, Texas, United States, 78207
      • Ep0034 630
  • Washington
    • Seattle, Washington, United States, 98105-0371
      • Ep0034 114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Drug: Lacosamide; 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; Other Names: VIMPAT; Drug: Lacosamide; Pharmaceutical form: tablet Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day) Route of administration: oral use; Other Names: VIMPAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Seizure-free Days During the Study	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.	From Week 0 to End of Treatment (up to Week 96)

Collaborators and Investigators

• Sponsor: UCB BIOSCIENCES, Inc.
• Collaborators: UCB Biopharma SRL

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2014
• Primary Completion (ACTUAL): April 13, 2022
• Study Completion (ACTUAL): April 13, 2022

Study Registration Dates

• First Submitted: October 14, 2013
• First Submitted That Met QC Criteria: October 14, 2013
• First Posted (ESTIMATE): October 17, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Epilepsy; Pediatric; Partial-Onset Seizures; Lacosamide; Vimpat; UCB
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: EP0034; 2012-005012-26 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR