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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04627285




Registration number
NCT04627285
Ethics application status
Date submitted
12/11/2020
Date registered
13/11/2020
Date last updated
25/11/2022

Titles & IDs
Public title
A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment
Scientific title
A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment
Secondary ID [1] 0 0
2020-001478-30
Secondary ID [2] 0 0
EP0151
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

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

Experimental: Lacosamide - Subjects in this arm will receive various single doses of lacosamide


Treatment: Drugs: Lacosamide
Pharmaceutical form: Oral-solution
Route of administration: Oral use
Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
From visit 1 (Week 0) to the end of study visit (up to Week 213)
Primary outcome [2] 0 0
Withdrawals from study due to TEAEs
Timepoint [2] 0 0
From visit 1 (Week 0) to the end of study visit (up to Week 213)
Primary outcome [3] 0 0
Withdrawals from study due to Serious Adverse Event (SAEs)
Timepoint [3] 0 0
From visit 1 (Week 0) to the end of study visit (up to Week 213)
Primary outcome [4] 0 0
Modal daily dose during the study
Timepoint [4] 0 0
From visit 1 (Week 0) to the end of study visit (up to Week 213)
Primary outcome [5] 0 0
Maximum daily dose during the study
Timepoint [5] 0 0
From visit 1 (Week 0) to the end of study visit (up to Week 213)

Eligibility
Key inclusion criteria
- Participant is male or female, aged <6 years at the time of signing the Informed
Consent Form (ICF)

- Participant has completed participation in NCT01964560 (EP0034) or NCT00938912 (SP848)

- Participant is expected to benefit from participation, in the opinion of the
Investigator
Minimum age
2 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant has any medical or psychiatric condition that, in the opinion of the
Investigator, could jeopardize or would compromise the study participant's ability to
participate in this study

- Participant has a known hypersensitivity to any components of the study medication or
comparative drugs as stated in this protocol

- Participant is receiving any investigational drugs or using any experimental devices
in addition to lacosamide (LCM)

- Participant meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for
NCT01964560 (EP0034) or NCT00938912 (SP848), or is experiencing an ongoing serious
adverse event (SAE)

- Sensitivity to any of the study interventions, or components thereof, or drug or other
allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates
participation in the study

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
28/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Georgia
State/province [1] 0 0
Tbilisi
Country [2] 0 0
Hungary
State/province [2] 0 0
Budapest
Country [3] 0 0
Moldova, Republic of
State/province [3] 0 0
Chisinau
Country [4] 0 0
Romania
State/province [4] 0 0
Bucuresti
Country [5] 0 0
Romania
State/province [5] 0 0
Iasi
Country [6] 0 0
Romania
State/province [6] 0 0
Timisoara
Country [7] 0 0
Taiwan
State/province [7] 0 0
Taipei
Country [8] 0 0
Ukraine
State/province [8] 0 0
Dnipropetrovsk
Country [9] 0 0
Ukraine
State/province [9] 0 0
Dnipro
Country [10] 0 0
Ukraine
State/province [10] 0 0
Kiev
Country [11] 0 0
Ukraine
State/province [11] 0 0
Uzhgorod
Country [12] 0 0
Ukraine
State/province [12] 0 0
Vinnytsya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Biopharma SRL
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at
2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy
who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04627285
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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