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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01964560
Ethics application status
Date submitted
14/10/2013
Date registered
17/10/2013
Date last updated
29/06/2020

Titles & IDs
Public title
Long-term Extension Study to Investigate Lacosamide as an Add-on Therapy in Children 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
Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) during the study (TEAE) during the study
Timepoint [1] 0 0
Week 0 to the End of Treatment (approximately 96 weeks)
Primary outcome [2] 0 0
Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) leading to discontinuation from the study
Timepoint [2] 0 0
Week 0 to End of Treatment (approximately 96 weeks)
Secondary outcome [1] 0 0
Percentage of Seizure Free Days at the End of Year 1
Timepoint [1] 0 0
End of Year 1 of the Study (approximately 52 weeks)
Secondary outcome [2] 0 0
Percentage of Seizure Free Days at the End of Year 2
Timepoint [2] 0 0
End of Year 2 of the Study (approximately 96 weeks)

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 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
Gender
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
N/A
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
200 - Melbourne
Recruitment hospital [2] 0 0
203 - Parkville
Recruitment hospital [3] 0 0
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
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Florida
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Kentucky
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Nevada
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New Hampshire
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North Carolina
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Oregon
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Washington
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Belgium
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Brussels
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Brazil
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Brazil
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Sao Paulo
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Bulgaria
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Sofia
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Beijing
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China
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Nanchang
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China
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Shenzhen
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Medellin
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Osijek
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Rijeka
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Zagreb
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Hradec Kralove
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Prague
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Praha
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Tallinn
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Estonia
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Tartu
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France
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Rennes
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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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Debrecen
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Miskolc
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Pecs
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Genova
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Mantova
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Messina
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Roma
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Suceava
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Voronezh
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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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Bardejov
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Úzhgorod
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Cambridge
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United Kingdom
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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
PRA Health Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Study to evaluate the long-term safety and tolerability of Lacosamide (LCM) administered in
addition to 1 to =3 other Anti-Epileptic Drugs in subjects with epilepsy =1 month to =18
years who currently have uncontrolled partial onset seizures.
Trial website
https://clinicaltrials.gov/show/NCT01964560
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
+1 844 599 2273
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
Other publications