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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

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
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United States of America
State/province [3] 0 0
Kentucky
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United States of America
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Nevada
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United States of America
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New Hampshire
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United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Cordoba
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
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Brazil
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Passo Fundo
Country [14] 0 0
Brazil
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Sao Paulo
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Bulgaria
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Plovdiv
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China
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Beijing
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China
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Changchun
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China
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Chongqing
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China
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Nanchang
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China
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Shanghai
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China
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Shenzhen
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Colombia
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Medellin
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Croatia
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Osijek
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Croatia
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Rijeka
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Croatia
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Zagreb
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Czechia
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Hradec Kralove
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Czechia
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Ostrava-poruba
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Czechia
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Praha 4 - Krc
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Czechia
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Praha 5
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Estonia
State/province [30] 0 0
Tallinn
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Estonia
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Tartu
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France
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Rennes Cedex 2
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France
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Strasbourg Cedex
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Georgia
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Tbilisi
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Greece
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Athens
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Miskolc
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Hungary
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Pecs
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Israel
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Petah Tiqwa
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Italy
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Genova
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Italy
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Mantova
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Italy
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Messina
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Italy
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Milano
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Italy
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Padova
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Italy
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Roma
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Italy
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Verona
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Korea, Republic of
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Daegu
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Seoul
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Riga
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Mexico
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Mexico
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Monterrey
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Moldova, Republic of
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Chisinau
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Montenegro
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Podgorica
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Philippines
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Cebu
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Manila
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Gdansk
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Kielce
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Krakow
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Poznan
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Tyniec Maly
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Warszawa
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Wroclaw
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Portugal
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Lisbon
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Romania
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Bucuresti
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Cluj-napoca
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Iasi
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Sibiu
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Suceava
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Timisoara
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Russian Federation
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Ekaterinburg
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Kazan
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Kemerovo
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Novosibirsk
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Russian Federation
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Omsk
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Perm
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Saint Petersburg
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Voronezh
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Novi Sad
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Slovakia
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Bardejov
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Slovakia
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Nove Zamky
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Slovenia
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Ljubljana
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Taiwan
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Changhua City
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Taiwan
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Taichung
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Taiwan
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Taipei
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Thailand
State/province [98] 0 0
Bangkoknoi
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Thailand
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Pathum Wan
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Thailand
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Ratchathewi
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Thailand
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Tha Muang
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Ukraine
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Dnipro
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Ukraine
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Ivano-frankivsk
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Ukraine
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Kiev
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Ukraine
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Uzhgorod
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Ukraine
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.Vivli.org


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01964560