A Phase 3 interventional study of Lacosamide in Epilepsy, sponsored by UCB Biopharma SRL. Completed at 15 sites in 6 countries. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by UCB Biopharma SRL · Phase 3, Interventional, and Treatment
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).
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects in this arm will receive various single doses of lacosamide
Drug: Lacosamide
* Pharmaceutical form: Oral-solution * Route of administration: Oral use Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
The study started to enroll participants in December 2020 and concluded in February 2025.
| Milestone | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years |
|---|---|---|
| Started | 19 | 29 |
| Completed | 12 | 25 |
| Not completed | 7 | 4 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Sponsor decision | 5 | 0 |
| Withdrew: Participant left country; aunt informed the site | 0 | 1 |
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.
| percentage of participants | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | 42.1 | 37.9 |
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.
| percentage of participants | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years |
|---|---|---|
| Percentage of Participants Who Withdrew From Study Due to TEAEs | 0.0 | 6.9 |
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.
| percentage of participants | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years |
|---|---|---|
| Percentage of Participants Who Withdrew From Study Due to Serious Adverse Event (SAEs) | 0.0 | 6.9 |
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.
| mg/kg/day | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years |
|---|---|---|
| Modal Daily Dose During the Study | 9.5 ± 2.4 | 10.0 ± 2.6 |
Maximum daily dose is defined as the highest total daily dose a participant received in EP0151.
| mg/kg/day | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years |
|---|---|---|
| Maximum Daily Dose During the Study | 9.5 ± 2.4 | 10.1 ± 2.6 |
Collected over From visit 1 (Week 0) to the end of study visit (up to Week 214.42). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lacosamide: >=2 to <4 Years | 0/19 (0%) | 2/19 (10.5%) | 5/19 (26.3%) |
| Lacosamide: >=4 to <6 Years | 2/29 (6.9%) | 5/29 (17.2%) | 4/29 (13.8%) |
| Event | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years |
|---|---|---|
| BronchopneumoniaInfections and infestations | 1/19 | 0/29 |
| PneumoniaInfections and infestations | 1/19 | 0/29 |
| Septic shockInfections and infestations | 1/19 | 0/29 |
| EpilepsyNervous system disorders | 1/19 | 0/29 |
| Cardiac failure acuteCardiac disorders | 0/19 | 1/29 |
| Developmental hip dysplasiaCongenital, familial and genetic disorders | 0/19 | 1/29 |
| Device malfunctionGeneral disorders | 0/19 | 1/29 |
| Sudden deathGeneral disorders | 0/19 | 1/29 |
| Pneumonia necrotisingInfections and infestations | 0/19 | 1/29 |
| Rhinovirus infectionInfections and infestations | 0/19 | 1/29 |
| Event | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 5/19 | 4/29 |
The SS consisted of all study participants who signed an informed consent form (ICF) and took at least 1 dose of study medication in this study.
| Age, Continuous(years) | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years | Total |
|---|---|---|---|
| Mean | 2.888 ± 0.518 | 5.180 ± 0.642 | 4.273 ± 1.277 |
| Age, Customized(Participants) | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years | Total |
|---|---|---|---|
| Greater than or equal to (>=) 24 months to less than (<) 12 years | 19 | 29 | 48 |
| Sex: Female, Male(Participants) | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years | Total |
|---|---|---|---|
| Female | 6 | 9 | 15 |
| Male | 13 | 20 | 33 |
| Race/Ethnicity, Customized(Participants) | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years | Total |
|---|---|---|---|
| Race — Asian | 1 | 1 | 2 |
| Race — White | 18 | 28 | 46 |
| Race/Ethnicity, Customized(Participants) | Lacosamide: >=2 to <4 Years | Lacosamide: >=4 to <6 Years | Total |
|---|---|---|---|
| Ethnicity — Hispanic or Latino | 0 | 3 | 3 |
| Ethnicity — Not Hispanic or Latino | 19 | 26 | 45 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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 information: Study protocol, Sap, Csr
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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