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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001478-30 | EudraCT Number | ||
| 2022-502639-21-00 | Registry Identifier | EU CT Number | |
| U1111-1286-3095 | Other Identifier | Universal Trial Number (UTN) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | Subjects in this arm will receive various single doses of lacosamide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug |
Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ep0151 620 | Tbilisi | Georgia | ||||
| Ep0151 621 |
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.
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.
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.
Participants who completed studies EP0034 (NCT01964560) or SP848 (NCT00938912) were offered participation in this study. The Participant Flow refers to the Safety Set (SS).
The study started to enroll participants in December 2020 and concluded in February 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide: >=2 to <4 Years | Participants aged greater than or equal to (>=) 2 to less than (<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2023 | Jul 21, 2025 |
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| 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) |
| 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 |
| FG001 | Lacosamide: >=4 to <6 Years | Participants aged >=4 to <6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator. |
| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide: >=2 to <4 Years | Participants aged greater than or equal to (>=) 2 to less than (<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator. |
| BG001 | Lacosamide: >=4 to <6 Years | Participants aged >=4 to <6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The SS consisted of all study participants who signed an ICF and took at least 1 dose of study medication in this study. | Posted | Number | percentage of participants | From visit 1 (Week 0) to the end of study visit (up to Week 214.42) |
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| Primary | 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. | The SS consisted of all study participants who signed an ICF and took at least 1 dose of study medication in this study. | Posted | Number | percentage of participants | From visit 1 (Week 0) to the end of study visit (up to Week 214.42) |
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| Primary | 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. | The SS consisted of all study participants who signed an ICF and took at least 1 dose of study medication in this study. | Posted | Number | percentage of participants | From visit 1 (Week 0) to the end of study visit (up to Week 214.42) |
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| Primary | 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. | The SS consisted of all study participants who signed an ICF and took at least 1 dose of study medication in this study. | Posted | Mean | Standard Deviation | mg/kg/day | From visit 1 (Week 0) to the end of study visit (up to Week 214.42) |
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| Primary | Maximum Daily Dose During the Study | Maximum daily dose is defined as the highest total daily dose a participant received in EP0151. | The SS consisted of all study participants who signed an ICF and took at least 1 dose of study medication in this study. | Posted | Mean | Standard Deviation | mg/kg/day | From visit 1 (Week 0) to the end of study visit (up to Week 214.42) |
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From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
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. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lacosamide: >=2 to <4 Years | Participants aged greater than or equal to (>=) 2 to less than (<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator. | 0 | 19 | 2 | 19 | 5 | 19 |
| EG001 | Lacosamide: >=4 to <6 Years | Participants aged >=4 to <6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator. | 2 | 29 | 5 | 29 | 4 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure acute | Cardiac disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Developmental hip dysplasia | Congenital, familial and genetic disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Device malfunction | General disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Sudden death | General disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA version 16.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 16.1 | Non-systematic Assessment |
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| Pneumonia necrotising | Infections and infestations | MedDRA version 16.1 | Non-systematic Assessment |
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| Rhinovirus infection | Infections and infestations | MedDRA version 16.1 | Non-systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA version 16.1 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA version 16.1 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Partial seizures with secondary generalisation | Nervous system disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1-844-599-2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 8, 2020 | Jul 21, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Male |
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| White |
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| Not Hispanic or Latino |
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Participants aged >=4 to <6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator. |
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