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
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
4 other identifiers
interventional
48
6 countries
15
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2020
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedStudy Start
First participant enrolled
December 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2025
CompletedResults Posted
Study results publicly available
August 28, 2025
CompletedAugust 28, 2025
August 1, 2025
4.1 years
November 12, 2020
August 11, 2025
August 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant 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. Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent.
From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Percentage of Participants Who Withdrew From Study Due to TEAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant 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. Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent.
From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Percentage of Participants Who Withdrew From Study Due to Serious Adverse Event (SAEs)
A SAE is defined as results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect, 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. Only participants who discontinued the study due to SAEs are reported.
From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Modal Daily Dose During the Study
The modal daily LCM dose in milligram per kilogram (mg/kg/day) is defined as the daily Lacosamide dose the participant received for the longest duration in EP0151.
From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Maximum Daily Dose During the Study
Maximum daily dose is defined as the highest total daily dose a participant received in EP0151.
From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Study Arms (1)
Lacosamide
EXPERIMENTALSubjects in this arm will receive various single doses of lacosamide
Interventions
* Pharmaceutical form: Oral-solution * Route of administration: Oral use Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Ep0151 620
Tbilisi, Georgia
Ep0151 621
Tbilisi, Georgia
Ep0151 622
Tbilisi, Georgia
Ep0151 361
Budapest, Hungary
Ep0151 362
Budapest, Hungary
Ep0151 650
Chisinau, Moldova
Ep0151 581
Bucharest, Romania
Ep0151 582
Iași, Romania
Ep0151 577
Timișoara, Romania
Ep0151 224
Taipei, Taiwan
Ep0151 602
Dnipro, Ukraine
Ep0151 609
Dnipropetrovsk, Ukraine
Ep0151 606
Kiev, Ukraine
Ep0151 682
Uzhhorod, Ukraine
Ep0151 603
Vinnytsia, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2020
First Posted
November 13, 2020
Study Start
December 28, 2020
Primary Completion
February 12, 2025
Study Completion
February 12, 2025
Last Updated
August 28, 2025
Results First Posted
August 28, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- 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.
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.