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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001558-27 | EudraCT Number |
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The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to 3 other antiepileptic drugs (AEDs).
Six subjects aged 5-11 (Cohort 1) were initially enrolled at the 8 mg/kg/day dose level. Upon completion of the study for these subjects, pharmacokinetic and safety data were analyzed to determine the target dose for the remaining subjects (either 8, 10 or 12 mg/kg/day). Depending on the selected target dose, four additional age-based cohorts of subjects were to be enrolled. LCM was increased 2 mg/kg/day per week until the target dose or maximum dose able to be tolerated was achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide - Age 5 - 11 years | Experimental | Cohort 1 (Age 5 - 11 years); up to 8 mg/kg/day |
|
| Lacosamide - (Age 12 - 17 years) | Experimental | Cohort 2 (Age 12 - 17 years); 12 mg/kg/day. |
|
| Lacosamide (Age 2 - 4 years) | Experimental | Cohort 3 (Age 2 - 4 years); 12 mg/kg/day. |
|
| Lacosamide (Age 5 - 11 years) | Experimental | Cohort 4 (Age 5 - 11 years); 12 mg/kg/day. |
|
| Lacosamide (Age 1 month - < 2 years) | Experimental | Cohort 5 (Age 1 month to < 2 years); 12 mg/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks) | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Seizure Frequency From Baseline to End of Treatment | From Baseline to End of Treatment (approximately 13 weeks) | |
| Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination | For the assessment of the Caregiver Global Impression of Change, the caregiver (including parent/legal guardian) provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of Adverse Events (AEs), and subject's functional status. The caregiver will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 025 | Sacramento | California | United States | |||
| 002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30427550 | Result | Winkler J, Schoemaker R, Stockis A. Population Pharmacokinetics of Adjunctive Lacosamide in Pediatric Patients With Epilepsy. J Clin Pharmacol. 2019 Apr;59(4):541-547. doi: 10.1002/jcph.1340. Epub 2018 Nov 14. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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The SP0847 study began recruitment in October 2009. The study ended in July 2014 with 47 subjects enrolled into the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | >=1 Month to <4 Years (Safety Set) | Subjects were classified as belonging to the age group based on their age at time of enrollment |
| FG001 | >=4 Years to <12 Years (Safety Set) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| Visit 5 (Day 27/28) or Early Termination |
| Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination | For assessment of the Clinical Global Impression of Change, the investigator provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status. The investigator will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:
| Visit 5 (Day 27/28) or Early Termination |
| Plasma Ctrough Values for Lacosamide at Day 7 | During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Day 7 |
| Plasma Ctrough Values for Lacosamide at Day 28 | During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Day 28 |
| Plasma Ctrough Values for Lacosamide at Day 35 | During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Day 35 |
| Plasma Ctrough Values for Lacosamide at Day 42 | During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Day 42 |
| Plasma Ctrough Values for SPM 12809 at Day 7 | SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Day 7 |
| Plasma Ctrough Values for SPM 12809 at Day 28 | SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Day 28 |
| Plasma Ctrough Values for SPM 12809 at Day 35 | SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Day 35 |
| Plasma Ctrough Values for SPM 12809 at Day 42 | SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Day 42 |
| Washington D.C. |
| District of Columbia |
| United States |
| 012 | Tampa | Florida | United States |
| 019 | Wellington | Florida | United States |
| 006 | Saint Paul | Minnesota | United States |
| 008 | Kansas City | Missouri | United States |
| 015 | New Brunswick | New Jersey | United States |
| 005 | Durham | North Carolina | United States |
| 001 | Philadelphia | Pennsylvania | United States |
| 016 | Pittsburgh | Pennsylvania | United States |
| 004 | Nashville | Tennessee | United States |
| 026 | Austin | Texas | United States |
| 022 | Houston | Texas | United States |
| 020 | Norfolk | Virginia | United States |
| 201 | Brussels | Belgium |
| 200 | Edegem | Belgium |
| 202 | Leuven | Belgium |
| 101 | Culiacán | Mexico |
| 104 | Guadalajara | Mexico |
| 105 | Monterrey | Mexico |
| 103 | San Luis Potosí City | Mexico |
Subjects were classified as belonging to the age group based on their age at time of enrollment
| FG002 | >=12 Years to <=17 Years (Safety Set) | Subjects were classified as belonging to the age group based on their age at time of enrollment |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis group for Baseline Characteristics is the Safety Set (SS). The SS is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | >=1 Month to <4 Years (Safety Set) | Subjects were classified as belonging to the age group based on their age at time of enrollment |
| BG001 | >=4 Years to <12 Years (Safety Set) | Subjects were classified as belonging to the age group based on their age at time of enrollment |
| BG002 | >=12 Years to <=17 Years (Safety Set) | Subjects were classified as belonging to the age group based on their age at time of enrollment |
| BG003 | Total Title |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Racial Group | Number | participants |
| ||||||||||||||||
| Ethnicity | Number | participants |
|
| 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 | Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks) | The analysis consists of the Safety Set (SS), which is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847. | Posted | Number | participants | 13 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Seizure Frequency From Baseline to End of Treatment | This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study. | Posted | Mean | Standard Deviation | percentage change | From Baseline to End of Treatment (approximately 13 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination | For the assessment of the Caregiver Global Impression of Change, the caregiver (including parent/legal guardian) provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of Adverse Events (AEs), and subject's functional status. The caregiver will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:
| This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study. | Posted | Number | Participants | Visit 5 (Day 27/28) or Early Termination |
| ||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination | For assessment of the Clinical Global Impression of Change, the investigator provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status. The investigator will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:
| This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study. For one subject in the age group >=12 years to <=17 years no data is available. | Posted | Number | Participants | Visit 5 (Day 27/28) or Early Termination |
| ||||||||||||||||||||||||||||||||||
| Secondary | Plasma Ctrough Values for Lacosamide at Day 7 | During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 7 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Plasma Ctrough Values for Lacosamide at Day 28 | During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 28 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Plasma Ctrough Values for Lacosamide at Day 35 | During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 35 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Plasma Ctrough Values for Lacosamide at Day 42 | During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 42 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Plasma Ctrough Values for SPM 12809 at Day 7 | SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 7 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Ctrough Values for SPM 12809 at Day 28 | SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 28 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Ctrough Values for SPM 12809 at Day 35 | SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 35 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Ctrough Values for SPM 12809 at Day 42 | SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 42 |
|
Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set.
The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
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 | >=1 Month to <4 Years (Safety Set) | Subjects were classified as belonging to the age group based on their age at time of enrollment | 3 | 15 | 11 | 15 | ||
| EG001 | >=4 Years to <12 Years (Safety Set) | Subjects were classified as belonging to the age group based on their age at time of enrollment | 3 | 23 | 16 | 23 | ||
| EG002 | >=12 Years to <=17 Years (Safety Set) | Subjects were classified as belonging to the age group based on their age at time of enrollment | 0 | 9 | 7 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA16.1 | Non-systematic Assessment |
|
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | UCB | +1877 822 9493 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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
| Male |
|
| Black |
|
| White |
|
| Other/ Mixed |
|
| Not Hispanic or Latino |
|
|
Subjects were classified as belonging to the age group based on their age at time of enrollment |
|
|
| >=12 Years to <=17 Years (Full Analysis Set) |
Subjects were classified as belonging to the age group based on their age at time of enrollment |
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