Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01964560




Registration number
NCT01964560
Ethics application status
Date submitted
14/10/2013
Date registered
17/10/2013
Date last updated
25/10/2022

Titles & IDs
Public title
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
Scientific 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
Secondary ID [1] 0 0
2012-005012-26
Secondary ID [2] 0 0
EP0034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Lacosamide
Treatment: Drugs - Lacosamide

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.


Treatment: Drugs: 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

Treatment: Drugs: Lacosamide
Pharmaceutical form: tablet

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

Route of administration: oral use
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From Week 0 to the End of Safety Follow-Up (up to Week 104)
Primary outcome [2] 0 0
Percentage of Participants With Serious TEAEs
Timepoint [2] 0 0
From Week 0 to the End of Safety Follow-Up (up to Week 104)
Primary outcome [3] 0 0
Percentage of Participants With TEAEs Leading to Study Discontinuation
Timepoint [3] 0 0
From Week 0 to the End of Safety Follow-Up (up to Week 104)
Secondary outcome [1] 0 0
Percentage of Seizure-free Days During the Study
Timepoint [1] 0 0
From Week 0 to End of Treatment (up to Week 96)

Eligibility
Key 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
Minimum age
1 Month
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/04/2022
Sample size
Target
Accrual to date
Final
540
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ep0034 200 - Melbourne
Recruitment hospital [2] 0 0
Ep0034 203 - Parkville
Recruitment hospital [3] 0 0
Ep0034 205 - South Brisbane
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Parkville
Recruitment postcode(s) [3] 0 0
- South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Nevada
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Argentina
State/province [10] 0 0
Ciudad Autonoma de Buenos Aire
Country [11] 0 0
Argentina
State/province [11] 0 0
Cordoba
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Brazil
State/province [13] 0 0
Passo Fundo
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Plovdiv
Country [16] 0 0
China
State/province [16] 0 0
Beijing
Country [17] 0 0
China
State/province [17] 0 0
Changchun
Country [18] 0 0
China
State/province [18] 0 0
Chongqing
Country [19] 0 0
China
State/province [19] 0 0
Nanchang
Country [20] 0 0
China
State/province [20] 0 0
Shanghai
Country [21] 0 0
China
State/province [21] 0 0
Shenzhen
Country [22] 0 0
Colombia
State/province [22] 0 0
Medellin
Country [23] 0 0
Croatia
State/province [23] 0 0
Osijek
Country [24] 0 0
Croatia
State/province [24] 0 0
Rijeka
Country [25] 0 0
Croatia
State/province [25] 0 0
Zagreb
Country [26] 0 0
Czechia
State/province [26] 0 0
Hradec Kralove
Country [27] 0 0
Czechia
State/province [27] 0 0
Ostrava-poruba
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 4 - Krc
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 5
Country [30] 0 0
Estonia
State/province [30] 0 0
Tallinn
Country [31] 0 0
Estonia
State/province [31] 0 0
Tartu
Country [32] 0 0
France
State/province [32] 0 0
Rennes Cedex 2
Country [33] 0 0
France
State/province [33] 0 0
Strasbourg Cedex
Country [34] 0 0
Georgia
State/province [34] 0 0
Tbilisi
Country [35] 0 0
Greece
State/province [35] 0 0
Athens
Country [36] 0 0
Hungary
State/province [36] 0 0
Budapest
Country [37] 0 0
Hungary
State/province [37] 0 0
Debrecen
Country [38] 0 0
Hungary
State/province [38] 0 0
Miskolc
Country [39] 0 0
Hungary
State/province [39] 0 0
Pecs
Country [40] 0 0
Israel
State/province [40] 0 0
Petah Tiqwa
Country [41] 0 0
Italy
State/province [41] 0 0
Genova
Country [42] 0 0
Italy
State/province [42] 0 0
Mantova
Country [43] 0 0
Italy
State/province [43] 0 0
Messina
Country [44] 0 0
Italy
State/province [44] 0 0
Milano
Country [45] 0 0
Italy
State/province [45] 0 0
Padova
Country [46] 0 0
Italy
State/province [46] 0 0
Roma
Country [47] 0 0
Italy
State/province [47] 0 0
Verona
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Daegu
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seoul
Country [50] 0 0
Latvia
State/province [50] 0 0
Riga
Country [51] 0 0
Latvia
State/province [51] 0 0
Valmiera
Country [52] 0 0
Lithuania
State/province [52] 0 0
Kaunas
Country [53] 0 0
Mexico
State/province [53] 0 0
Aguascalientes
Country [54] 0 0
Mexico
State/province [54] 0 0
Culiacan
Country [55] 0 0
Mexico
State/province [55] 0 0
Guadalajara
Country [56] 0 0
Mexico
State/province [56] 0 0
Mexico
Country [57] 0 0
Mexico
State/province [57] 0 0
Monterrey
Country [58] 0 0
Moldova, Republic of
State/province [58] 0 0
Chisinau
Country [59] 0 0
Montenegro
State/province [59] 0 0
Podgorica
Country [60] 0 0
Philippines
State/province [60] 0 0
Cebu
Country [61] 0 0
Philippines
State/province [61] 0 0
Manila
Country [62] 0 0
Poland
State/province [62] 0 0
Gdansk
Country [63] 0 0
Poland
State/province [63] 0 0
Kielce
Country [64] 0 0
Poland
State/province [64] 0 0
Krakow
Country [65] 0 0
Poland
State/province [65] 0 0
Poznan
Country [66] 0 0
Poland
State/province [66] 0 0
Tyniec Maly
Country [67] 0 0
Poland
State/province [67] 0 0
Warszawa
Country [68] 0 0
Poland
State/province [68] 0 0
Wroclaw
Country [69] 0 0
Portugal
State/province [69] 0 0
Lisbon
Country [70] 0 0
Romania
State/province [70] 0 0
Bucuresti
Country [71] 0 0
Romania
State/province [71] 0 0
Cluj-napoca
Country [72] 0 0
Romania
State/province [72] 0 0
Iasi
Country [73] 0 0
Romania
State/province [73] 0 0
Sibiu
Country [74] 0 0
Romania
State/province [74] 0 0
Suceava
Country [75] 0 0
Romania
State/province [75] 0 0
Timisoara
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Ekaterinburg
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Kazan
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Kemerovo
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Moscow
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Nizhniy Novgorod
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Novosibirsk
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Omsk
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Perm
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Saint Petersburg
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Smolensk
Country [86] 0 0
Russian Federation
State/province [86] 0 0
St. Petersburg
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Tomsk
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Voronezh
Country [89] 0 0
Serbia
State/province [89] 0 0
Belgrade
Country [90] 0 0
Serbia
State/province [90] 0 0
Kragujevac
Country [91] 0 0
Serbia
State/province [91] 0 0
Novi Sad
Country [92] 0 0
Slovakia
State/province [92] 0 0
Bardejov
Country [93] 0 0
Slovakia
State/province [93] 0 0
Nove Zamky
Country [94] 0 0
Slovenia
State/province [94] 0 0
Ljubljana
Country [95] 0 0
Taiwan
State/province [95] 0 0
Changhua City
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taichung
Country [97] 0 0
Taiwan
State/province [97] 0 0
Taipei
Country [98] 0 0
Thailand
State/province [98] 0 0
Bangkoknoi
Country [99] 0 0
Thailand
State/province [99] 0 0
Pathum Wan
Country [100] 0 0
Thailand
State/province [100] 0 0
Ratchathewi
Country [101] 0 0
Thailand
State/province [101] 0 0
Tha Muang
Country [102] 0 0
Ukraine
State/province [102] 0 0
Dnipro
Country [103] 0 0
Ukraine
State/province [103] 0 0
Ivano-frankivsk
Country [104] 0 0
Ukraine
State/province [104] 0 0
Kiev
Country [105] 0 0
Ukraine
State/province [105] 0 0
Uzhgorod
Country [106] 0 0
Ukraine
State/province [106] 0 0
Vinnytsia
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Cambridge
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB BIOSCIENCES, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
UCB Biopharma SRL
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
Trial website
https://clinicaltrials.gov/study/NCT01964560
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01964560