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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964560
• Other study ID #: EP0034
• Secondary ID: 2012-005012-26
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

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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