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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01964560
Other study ID # EP0034
Secondary ID 2012-005012-26
Status Completed
Phase Phase 3
First received
Last updated
Start date August 13, 2014
Est. completion date April 13, 2022

Study information

Verified date September 2022
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 540
Est. completion date April 13, 2022
Est. primary completion date April 13, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Month to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
UCB BIOSCIENCES, Inc. UCB Biopharma SRL

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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 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)
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