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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000717-20 | EudraCT Number |
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The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled partial-onset seizures.
The trial consists of a 7-day Baseline Period, a 20-day Titration Period, a 7-day Maintenance Period, and a 12-day Transition Period for subjects who complete the study and choose to enter the extension study. Subjects who will not enter the extension study will continue after the Maintenance Period with a 16-day Taper Period followed by a 30-day Safety Follow-Up Period. The Taper Period and Safety Follow-Up are also applicable for subjects not eligible for continuation and therefore ending the study earlier.
If subjects meet the eligibility criteria, they will be randomized to receive either lacosamide 8 mg/kg/day to 12 mg/kg/day, or placebo during the Maintenance Phase. The dose of lacosamide will be titrated from 4 mg/kg/day at study start to maximum of 12 mg/kg/day at 4-day intervals of 1-2 mg/kg/day.
All subjects who complete the 20-day Titration Period will enter the 7-day Maintenance Period. No dose adjustment is allowed during the Maintenance Phase. The Treatment Phase is defined as the combined Titration and Maintenance Phases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | Lacosamide syrup 8 mg/kg/day to 12 mg/kg/day |
|
| Placebo | Placebo Comparator | Matching placebo syrup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | Active Substance: Lacosamide Pharmaceutical Form: Syrup Concentration: 10 mg/mL Route of Administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | The change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-electroencephalogram (EEG) compared to the End-of-Baseline Period video-EEG. Seizure frequency was analyzed using an analysis of covariance (ANCOVA) with terms for treatment, pooled randomized age stratum, pooled center, and Baseline seizure ADF. Seizure ADF was log transformed using the transformation of ln(X+1), where X is the seizure ADF. Baseline seizure ADF was log transformed. Least squares means were based on log-transformed data of the full ANCOVA model. | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
| Participant Withdrawals Due to Adverse Events (AEs) During the Study | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. | From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days) |
| Percentage of Participants With Adverse Events Reported Spontaneously by the Participant's Parent(s) and/or Legal Representative(s)/Caregiver(s) (in Accordance With Local Regulation) or Observed by the Investigator | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. | From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | The absolute change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG. | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sp0967 638 | Birmingham | Alabama | 35233 | United States | ||
| Sp0967 117 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38375995 | Derived | Makedonska I, Ng YT, Beller C, Bozorg A, Csikos J, McClung C, Moeltgen H, Farkas MK; SP0967 Study Group. Efficacy and tolerability of adjunctive lacosamide in patients aged <4 years with focal seizures. Ann Clin Transl Neurol. 2024 Mar;11(3):768-779. doi: 10.1002/acn3.52004. Epub 2024 Feb 20. |
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Completed study was defined as participants who had "Completed study participant" selected as status at termination. The total number of participants who completed the study comprises of those who completed the Transition Period and the ones that completed the Taper Period after completing the Maintenance Period.
Participant Flow refers to the SS.
The study started to enroll patients in June 2015 and concluded in May 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo syrup. |
| FG001 | Lacosamide | Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day. |
| 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 | Apr 5, 2018 | May 26, 2021 |
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| Placebo | Other | Active Substance: Placebo Pharmaceutical Form: Syrup Concentration: N/A Route of Administration: oral |
|
|
| Percent Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | The percent change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG. | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
| Percentage of Participants Who Achieved 'Seizure-free' Status From All Seizure Types During the End-of-Maintenance (EOM) Period Video-EEG | A study participant was considered seizure-free from all seizures if the End-of-Maintenance (EOM) Period video-EEG had zero seizures reported from all seizure types (not just partial-onset seizures (POS)). | During the End-of-Maintenance Period (Day 24 to Day 27) |
| Percentage of Participants Who Achieved 'Seizure-free' Status From Partial-onset Seizure Types Only During the End-of-Maintenance (EOM) Period Video-EEG | A study participant was considered seizure free from partial-onset seizures (POS) if the End-of-Maintenance (EOM) Period video-EEG had zero POS reported. | During the End-of-Maintenance Period (Day 24 to Day 27) |
| Percentage of Participants Experiencing a >=25% to <50% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | A ≥25% to <50% response was defined as ≥25% to <50% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
| Percentage of Participants Experiencing a 50% to 75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | A ≥50% to ≤75% response was defined as ≥50% to ≤75% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
| Percentage of Participants Experiencing a >75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | A >75% response was defined as >75% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
| Percentage of Participants Experiencing no Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures (Between <25% Reduction and <25% Increase) From EOB Period Video-EEG to EOM Period Video-EEG | No change was defined as between <25% reduction and <25% increase in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
| Percentage of Participants Experiencing an Increase in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures of >=25% From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | An increase was defined as ≥25% increase in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
| Tampa |
| Florida |
| 33609 |
| United States |
| Sp0967 115 | Henderson | Nevada | 89052 | United States |
| Sp0967 120 | Lebanon | New Hampshire | 03756 | United States |
| Sp0967 129 | Dallas | Texas | 75235 | United States |
| Sp0967 630 | San Antonio | Texas | 78207 | United States |
| Sp0967 643 | San Antonio | Texas | 78249 | United States |
| Sp0967 142 | Córdoba | Argentina |
| Sp0967 158 | Passo Fundo | Brazil |
| Sp0967 152 | Porto Alegre | Brazil |
| Sp0967 150 | São Paulo | Brazil |
| Sp0967 154 | São Paulo | Brazil |
| Sp0967 310 | Plovdiv | Bulgaria |
| Sp0967 530 | Beijing | China |
| Sp0967 535 | Changchun | China |
| Sp0967 532 | Chongqing | China |
| Sp0967 536 | Nanchang | China |
| Sp0967 531 | Shanghai | China |
| Sp0967 537 | Shenzhen | China |
| Sp0967 613 | Osijek | Croatia |
| Sp0967 610 | Rijeka | Croatia |
| Sp0967 612 | Zagreb | Croatia |
| Sp0967 320 | Ostrava-Poruba | Czechia |
| Sp0967 349 | Marseille | France |
| Sp0967 346 | Rennes | France |
| Sp0967 344 | Strasbourg | France |
| Sp0967 620 | Tbilisi | Georgia |
| Sp0967 621 | Tbilisi | Georgia |
| Sp0967 622 | Tbilisi | Georgia |
| Sp0967 623 | Tbilisi | Georgia |
| Sp0967 542 | Athens | Greece |
| Sp0967 361 | Budapest | Hungary |
| Sp0967 362 | Budapest | Hungary |
| Sp0967 363 | Budapest | Hungary |
| Sp0967 364 | Budapest | Hungary |
| Sp0967 368 | Budapest | Hungary |
| Sp0967 374 | Petah Tikva | Israel |
| Sp0967 397 | Genova | Italy |
| Sp0967 398 | Messina | Italy |
| Sp0967 381 | Milan | Italy |
| Sp0967 700 | Naples | Italy |
| Sp0967 383 | Roma | Italy |
| Sp0967 395 | Roma | Italy |
| Sp0967 694 | Aguascalientes | Mexico |
| Sp0967 561 | Chihuahua City | Mexico |
| Sp0967 569 | Culiacán | Mexico |
| Sp0967 693 | Culiacán | Mexico |
| Sp0967 563 | Guadalajara | Mexico |
| Sp0967 564 | México | Mexico |
| Sp0967 568 | Monterrey | Mexico |
| Sp0967 692 | Monterrey | Mexico |
| Sp0967 650 | Chisinau | Moldova |
| Sp0967 720 | Cebu | Philippines |
| Sp0967 724 | Cebu | Philippines |
| Sp0967 721 | Manila | Philippines |
| Sp0967 723 | Manila | Philippines |
| Sp0967 727 | Quezon City | Philippines |
| Sp0967 422 | Krakow | Poland |
| Sp0967 750 | Lisbon | Portugal |
| Sp0967 581 | Bucharest | Romania |
| Sp0967 582 | Iași | Romania |
| Sp0967 573 | Sibiu | Romania |
| Sp0967 577 | Timișoara | Romania |
| Sp0967 454 | Kemerovo | Russia |
| Sp0967 456 | Nizhny Novgorod | Russia |
| Sp0967 452 | Novosibirsk | Russia |
| Sp0967 453 | Omsk | Russia |
| Sp0967 455 | Perm | Russia |
| Sp0967 730 | Smolensk | Russia |
| Sp0967 458 | Tomsk | Russia |
| Sp0967 459 | Ulyanovsk | Russia |
| Sp0967 450 | Yekaterinburg | Russia |
| Sp0967 461 | Belgrade | Serbia |
| Sp0967 464 | Belgrade | Serbia |
| Sp0967 463 | Novi Sad | Serbia |
| Sp0967 474 | Bratislava | Slovakia |
| Sp0967 212 | Seoul | South Korea |
| Sp0967 215 | Seoul | South Korea |
| Sp0967 224 | Taipei | Taiwan |
| Sp0967 237 | Bangkok | Thailand |
| Sp0967 235 | Pathum Wan | Thailand |
| Sp0967 602 | Dnipro | Ukraine |
| Sp0967 609 | Dnipro | Ukraine |
| Sp0967 681 | Ivano-Frankivsk | Ukraine |
| Sp0967 600 | Kiev | Ukraine |
| Sp0967 606 | Kiev | Ukraine |
| Sp0967 682 | Uzhhorod | Ukraine |
| Sp0967 603 | Vinnytsia | Ukraine |
| Completed Transition Period |
|
| Completed Taper After Maintenance |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to the Safety Set (SS) which consisted of all randomized study participants who took at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo syrup. |
| BG001 | Lacosamide | Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day. |
| BG002 | Total Title |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||||
| Sex: Female, Male | 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 | Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | The change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-electroencephalogram (EEG) compared to the End-of-Baseline Period video-EEG. Seizure frequency was analyzed using an analysis of covariance (ANCOVA) with terms for treatment, pooled randomized age stratum, pooled center, and Baseline seizure ADF. Seizure ADF was log transformed using the transformation of ln(X+1), where X is the seizure ADF. Baseline seizure ADF was log transformed. Least squares means were based on log-transformed data of the full ANCOVA model. | Full Analysis Set (FAS) included all study participants in the Safety Set (SS). The analysis consisted of all study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG. | Posted | Least Squares Mean | Standard Error | percent change | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Participant Withdrawals Due to Adverse Events (AEs) During the Study | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. | The Safety Set (SS) included all randomized study participants who took at least 1 dose of study medication. | Posted | Number | percentage of participants | From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days) |
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| Primary | Percentage of Participants With Adverse Events Reported Spontaneously by the Participant's Parent(s) and/or Legal Representative(s)/Caregiver(s) (in Accordance With Local Regulation) or Observed by the Investigator | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. | The Safety Set (SS) included all randomized study participants who took at least 1 dose of study medication. | Posted | Number | percentage of participants | From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days) |
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| Secondary | Absolute Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | The absolute change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG. | Full Analysis Set (FAS) included all study participants in the Safety Set (SS). The analysis consisted of all study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG. | Posted | Mean | Standard Deviation | seizures per day | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
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| Secondary | Percent Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | The percent change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG. | Full Analysis Set (FAS) included all study participants in the Safety Set (SS). The analysis consisted of all study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG. | Posted | Mean | Standard Deviation | percent change | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
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| Secondary | Percentage of Participants Who Achieved 'Seizure-free' Status From All Seizure Types During the End-of-Maintenance (EOM) Period Video-EEG | A study participant was considered seizure-free from all seizures if the End-of-Maintenance (EOM) Period video-EEG had zero seizures reported from all seizure types (not just partial-onset seizures (POS)). | Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who completed at least 48 hours of interpretable video-EEG recordings during the EOM Period video-EEG. | Posted | Number | percentage of participants | During the End-of-Maintenance Period (Day 24 to Day 27) |
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| Secondary | Percentage of Participants Who Achieved 'Seizure-free' Status From Partial-onset Seizure Types Only During the End-of-Maintenance (EOM) Period Video-EEG | A study participant was considered seizure free from partial-onset seizures (POS) if the End-of-Maintenance (EOM) Period video-EEG had zero POS reported. | Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who completed at least 48 hours of interpretable video-EEG recordings during the EOM Period video-EEG. | Posted | Number | percentage of participants | During the End-of-Maintenance Period (Day 24 to Day 27) |
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| Secondary | Percentage of Participants Experiencing a >=25% to <50% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | A ≥25% to <50% response was defined as ≥25% to <50% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. | Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG. | Posted | Number | percentage of participants | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
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| Secondary | Percentage of Participants Experiencing a 50% to 75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | A ≥50% to ≤75% response was defined as ≥50% to ≤75% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. | Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG. | Posted | Number | percentage of participants | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
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| Secondary | Percentage of Participants Experiencing a >75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | A >75% response was defined as >75% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. | Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG. | Posted | Number | percentage of participants | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
|
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| Secondary | Percentage of Participants Experiencing no Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures (Between <25% Reduction and <25% Increase) From EOB Period Video-EEG to EOM Period Video-EEG | No change was defined as between <25% reduction and <25% increase in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. | Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG. | Posted | Number | percentage of participants | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
|
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| Secondary | Percentage of Participants Experiencing an Increase in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures of >=25% From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG | An increase was defined as ≥25% increase in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. | Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG. | Posted | Number | percentage of participants | End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27) |
|
|
Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (SS) | Participants received matching placebo syrup, forming the Safety Set (SS). | 0 | 127 | 6 | 127 | 30 | 127 |
| EG001 | Lacosamide (SS) | Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the SS. | 0 | 128 | 6 | 128 | 31 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 7, 2020 | May 26, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Black |
|
| White |
|
| Other/Mixed |
|
| ANCOVA |
| =0.6895 |
| Percent reduction |
| 3.19 |
| 2-Sided |
| 95 |
| -13.59 |
| 17.50 |
| Other |
|
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