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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04627285
Registration number
NCT04627285
Ethics application status
Date submitted
12/11/2020
Date registered
13/11/2020
Date last updated
27/11/2023
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
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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
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Secondary ID [1]
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2020-001478-30
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Secondary ID [2]
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EP0151
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epilepsy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of treatment-emergent adverse events (TEAEs)
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Assessment method [1]
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An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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Timepoint [1]
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From visit 1 (Week 0) to the end of study visit (up to Week 213)
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Primary outcome [2]
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Withdrawals from study due to TEAEs
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Assessment method [2]
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An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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Timepoint [2]
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From visit 1 (Week 0) to the end of study visit (up to Week 213)
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Primary outcome [3]
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Withdrawals from study due to Serious Adverse Event (SAEs)
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Assessment method [3]
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* Results in death
* Is life-threatening
* Requires in patient hospitalization or prolongation of existing hospitalization
* Is a congenital anomaly or birth defect
* Is an infection that requires treatment parenteral antibiotics
* Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
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Timepoint [3]
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From visit 1 (Week 0) to the end of study visit (up to Week 213)
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Primary outcome [4]
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Modal daily dose during the study
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Assessment method [4]
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Modal daily dose, defined as most frequently administered dose per mg/kg/day.
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Timepoint [4]
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From visit 1 (Week 0) to the end of study visit (up to Week 213)
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Primary outcome [5]
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Maximum daily dose during the study
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Assessment method [5]
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Maximum daily dose, defined as the highest administered dose per mg/kg/day.
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Timepoint [5]
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From visit 1 (Week 0) to the end of study visit (up to Week 213)
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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
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Minimum age
2
Years
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Maximum age
5
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/07/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
48
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Georgia
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State/province [1]
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Tbilisi
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
UCB Biopharma SRL
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/study/NCT04627285
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Trial related presentations / publications
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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
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Contacts
Principal investigator
Name
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UCB Cares
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Address
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001 844 599 2273 (UCB)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04627285
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