A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures

NCT ID: NCT01964560

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-13
• Study Completion Date: 2022-04-13

Brief Summary

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

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lacosamide

Intervention Type: DRUG

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

Lacosamide

Intervention Type: DRUG

Pharmaceutical form: tablet

Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day)

Route of administration: oral use

Interventions

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

Intervention Type: DRUG

Lacosamide

Pharmaceutical form: tablet

Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day)

Route of administration: oral use

Intervention Type: DRUG

Other Intervention Names

VIMPAT; VIMPAT

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: collaborator

UCB BIOSCIENCES, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

Ep0034 638

Birmingham, Alabama, United States

Ep0034 105

Orlando, Florida, United States

Ep0034 117

Tampa, Florida, United States

Ep0034 124

Lexington, Kentucky, United States

Ep0034 115

Henderson, Nevada, United States

Ep0034 120

Lebanon, New Hampshire, United States

Ep0034 102

Charlotte, North Carolina, United States

Ep0034 640

Springfield, Oregon, United States

Ep0034 129

Dallas, Texas, United States

Ep0034 630

San Antonio, Texas, United States

Ep0034 114

Seattle, Washington, 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

Countries

United States; Argentina; Australia; Belgium; Brazil; Bulgaria; China; Colombia; Croatia; Czechia; Estonia; France; Georgia; Greece; Hungary; Israel; Italy; Latvia; Lithuania; Mexico; Moldova; Montenegro; Philippines; Poland; Portugal; Romania; Russia; Serbia; Slovakia; Slovenia; South Korea; Taiwan; Thailand; Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.ucb.com/_up/ucb_com_products/documents/Vimpat_Labeling_Oct_2021.pdf

Product Information

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2012-005012-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EP0034

Identifier Type: -

Identifier Source: org_study_id