A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Lacosamide - Age 5 - 11 years Cohort 1 (Age 5 - 11 years); up to 8 mg/kg/day |
Drug: Lacosamide
Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL
Other Names:
|
Experimental: Lacosamide - (Age 12 - 17 years) Cohort 2 (Age 12 - 17 years); 12 mg/kg/day. |
Drug: Lacosamide
Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL
Other Names:
|
Experimental: Lacosamide (Age 2 - 4 years) Cohort 3 (Age 2 - 4 years); 12 mg/kg/day. |
Drug: Lacosamide
Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL
Other Names:
|
Experimental: Lacosamide (Age 5 - 11 years) Cohort 4 (Age 5 - 11 years); 12 mg/kg/day. |
Drug: Lacosamide
Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL
Other Names:
|
Experimental: Lacosamide (Age 1 month - < 2 years) Cohort 5 (Age 1 month to < 2 years); 12 mg/kg/day |
Drug: Lacosamide
Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks) [13 weeks]
Secondary Outcome Measures
- 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 [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: Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
- Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination [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: Very much improved Much improved Minimally improved No Change Minimally worse Much worse Very much worse
- Plasma Ctrough Values for Lacosamide at Day 7 [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.
- Plasma Ctrough Values for Lacosamide at Day 28 [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.
- Plasma Ctrough Values for Lacosamide at Day 35 [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.
- Plasma Ctrough Values for Lacosamide at Day 42 [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.
- Plasma Ctrough Values for SPM 12809 at Day 7 [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.
- Plasma Ctrough Values for SPM 12809 at Day 28 [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.
- Plasma Ctrough Values for SPM 12809 at Day 35 [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.
- Plasma Ctrough Values for SPM 12809 at Day 42 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is male or female between 1 month and 17 years of age inclusive
-
Subject's Body Mass Index (BMI) is within the 5th to 95th percentile for his/her age group
-
Subject has a diagnosis of epilepsy with partial-onset seizures
-
Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment with at least 2 anti-epileptic drugs (AEDs) (concurrently or sequentially)
-
Subject has been observed to have at least 2 countable seizures in the 4-week period prior to Screening
-
Subject is on a stable dosage regimen of 1 to 3 AEDs
Exclusion Criteria:
-
Subject is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device
-
Subject with seizures that are uncountable due to clustering during the 8-week period prior to study entry
-
Subject is on a ketogenic or other specialized diet
-
Subject has a history of primary generalized epilepsy
-
Subject has a history of status epilepticus within the 6-month period prior to Screening
-
Subject is receiving concomitant treatment with felbamate or has received previous felbamate therapy within the last 6 months prior to Screening
-
Subject has taken or is currently taking vigabatrin
-
Subject is taking monoamine oxidase (MAO) inhibitors or narcotic analgesics
-
Subject has a lifetime history of suicide attempt, or has suicidal ideation in the past 6 months
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | 025 | Sacramento | California | United States | |
2 | 002 | Washington | District of Columbia | United States | |
3 | 012 | Tampa | Florida | United States | |
4 | 019 | Wellington | Florida | United States | |
5 | 006 | Saint Paul | Minnesota | United States | |
6 | 008 | Kansas City | Missouri | United States | |
7 | 015 | New Brunswick | New Jersey | United States | |
8 | 005 | Durham | North Carolina | United States | |
9 | 001 | Philadelphia | Pennsylvania | United States | |
10 | 016 | Pittsburgh | Pennsylvania | United States | |
11 | 004 | Nashville | Tennessee | United States | |
12 | 026 | Austin | Texas | United States | |
13 | 022 | Houston | Texas | United States | |
14 | 020 | Norfolk | Virginia | United States | |
15 | 201 | Brussels | Belgium | ||
16 | 200 | Edegem | Belgium | ||
17 | 202 | Leuven | Belgium | ||
18 | 101 | Culiacan | Mexico | ||
19 | 104 | Guadalajara | Mexico | ||
20 | 105 | Monterrey | Mexico | ||
21 | 103 | San Luis Potosi | Mexico |
Sponsors and Collaborators
- UCB Pharma
Investigators
- Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- SP0847
- 2011-001558-27
Study Results
Participant Flow
Recruitment Details | The SP0847 study began recruitment in October 2009. The study ended in July 2014 with 47 subjects enrolled into the study. |
---|---|
Pre-assignment Detail |
Arm/Group Title | >=1 Month to <4 Years (Safety Set) | >=4 Years to <12 Years (Safety Set) | >=12 Years to <=17 Years (Safety Set) |
---|---|---|---|
Arm/Group Description | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment |
Period Title: Overall Study | |||
STARTED | 15 | 23 | 9 |
COMPLETED | 9 | 14 | 1 |
NOT COMPLETED | 6 | 9 | 8 |
Baseline Characteristics
Arm/Group Title | >=1 Month to <4 Years (Safety Set) | >=4 Years to <12 Years (Safety Set) | >=12 Years to <=17 Years (Safety Set) | Total Title |
---|---|---|---|---|
Arm/Group Description | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment | |
Overall Participants | 15 | 23 | 9 | 47 |
Age (years) [Mean (Standard Deviation) ] | ||||
Age (years) |
1.58
(1.02)
|
7.41
(2.44)
|
15.15
(1.50)
|
7.03
(5.12)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
10
66.7%
|
9
39.1%
|
5
55.6%
|
24
51.1%
|
Male |
5
33.3%
|
14
60.9%
|
4
44.4%
|
23
48.9%
|
Weight (kilograms) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [kilograms] |
9.90
(3.31)
|
26.73
(10.20)
|
54.10
(10.49)
|
26.60
(17.64)
|
Height (centimeters) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [centimeters] |
79.64
(11.22)
|
121.81
(14.86)
|
158.93
(11.43)
|
115.46
(31.23)
|
BMI (kg/m^2) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [kg/m^2] |
15.27
(2.33)
|
17.39
(2.68)
|
21.38
(3.12)
|
17.48
(3.37)
|
Racial Group (participants) [Number] | ||||
Asian |
1
6.7%
|
1
4.3%
|
0
0%
|
2
4.3%
|
Black |
0
0%
|
4
17.4%
|
3
33.3%
|
7
14.9%
|
White |
7
46.7%
|
18
78.3%
|
5
55.6%
|
30
63.8%
|
Other/ Mixed |
7
46.7%
|
0
0%
|
1
11.1%
|
8
17%
|
Ethnicity (participants) [Number] | ||||
Hispanic or Latino |
11
73.3%
|
7
30.4%
|
3
33.3%
|
21
44.7%
|
Not Hispanic or Latino |
4
26.7%
|
16
69.6%
|
6
66.7%
|
26
55.3%
|
Outcome Measures
Title | Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks) |
---|---|
Description | |
Time Frame | 13 weeks |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | >=1 Month to <4 Years (Safety Set) | >=4 Years to <12 Years (Safety Set) | >=12 Years to <=17 Years (Safety Set) |
---|---|---|---|
Arm/Group Description | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment |
Measure Participants | 15 | 23 | 9 |
Number [participants] |
14
93.3%
|
19
82.6%
|
9
100%
|
Title | Change in Seizure Frequency From Baseline to End of Treatment |
---|---|
Description | |
Time Frame | From Baseline to End of Treatment (approximately 13 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | >=1 Month to <4 Years (Full Analysis Set) | >=4 Years to <12 Years (Full Analysis Set) | >=12 Years to <=17 Years (Full Analysis Set) |
---|---|---|---|
Arm/Group Description | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment |
Measure Participants | 14 | 23 | 9 |
Mean (Standard Deviation) [percentage change] |
18.94
(111.44)
|
18.38
(88.16)
|
34.59
(92.45)
|
Title | Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination |
---|---|
Description | 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: Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse |
Time Frame | Visit 5 (Day 27/28) or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | >=1 Month to <4 Years (Full Analysis Set) | >=4 Years to <12 Years (Full Analysis Set) | >=12 Years to <=17 Years (Full Analysis Set) |
---|---|---|---|
Arm/Group Description | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment |
Measure Participants | 14 | 23 | 9 |
Very Much Improved |
3
20%
|
2
8.7%
|
0
0%
|
Much Improved |
7
46.7%
|
8
34.8%
|
4
44.4%
|
Minimally Improved |
3
20%
|
8
34.8%
|
3
33.3%
|
No Change |
0
0%
|
2
8.7%
|
1
11.1%
|
Miniamally Worse |
0
0%
|
1
4.3%
|
0
0%
|
Much Worse |
0
0%
|
2
8.7%
|
0
0%
|
No data available |
1
6.7%
|
0
0%
|
1
11.1%
|
Title | Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination |
---|---|
Description | 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: Very much improved Much improved Minimally improved No Change Minimally worse Much worse Very much worse |
Time Frame | Visit 5 (Day 27/28) or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | >=1 Month to <4 Years (Full Analysis Set) | >=4 Years to <12 Years (Full Analysis Set) | >=12 Years to <=17 Years (Full Analysis Set) |
---|---|---|---|
Arm/Group Description | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment |
Measure Participants | 14 | 23 | 9 |
Very Much Improved |
2
13.3%
|
2
8.7%
|
0
0%
|
Much Improved |
6
40%
|
7
30.4%
|
7
77.8%
|
Minimally Improved |
4
26.7%
|
9
39.1%
|
1
11.1%
|
No Change |
1
6.7%
|
2
8.7%
|
0
0%
|
Minimally Worse |
0
0%
|
3
13%
|
0
0%
|
Much Worse |
1
6.7%
|
0
0%
|
0
0%
|
No data available |
0
0%
|
0
0%
|
1
11.1%
|
Title | Plasma Ctrough Values for Lacosamide at Day 7 |
---|---|
Description | 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. |
Time Frame | Day 7 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | All Subjects (Safety Set) |
---|---|
Arm/Group Description | All subjects from >=1 month to <=17 years |
Measure Participants | 45 |
Geometric Mean (Geometric Coefficient of Variation) [μg/mL] |
839.9
(64.1)
|
Title | Plasma Ctrough Values for Lacosamide at Day 28 |
---|---|
Description | 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. |
Time Frame | Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | All Subjects (Safety Set) |
---|---|
Arm/Group Description | All subjects from >=1 month to <=17 years |
Measure Participants | 6 |
Geometric Mean (Geometric Coefficient of Variation) [μg/mL] |
3886.0
(70.2)
|
Title | Plasma Ctrough Values for Lacosamide at Day 35 |
---|---|
Description | 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. |
Time Frame | Day 35 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | All Subjects (Safety Set) |
---|---|
Arm/Group Description | All subjects from >=1 month to <=17 years |
Measure Participants | 5 |
Geometric Mean (Geometric Coefficient of Variation) [μg/mL] |
4033.8
(52.5)
|
Title | Plasma Ctrough Values for Lacosamide at Day 42 |
---|---|
Description | 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. |
Time Frame | Day 42 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | All Subjects (Safety Set) |
---|---|
Arm/Group Description | All subjects from >=1 month to <=17 years |
Measure Participants | 14 |
Geometric Mean (Geometric Coefficient of Variation) [μg/mL] |
4169.5
(73.3)
|
Title | Plasma Ctrough Values for SPM 12809 at Day 7 |
---|---|
Description | 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. |
Time Frame | Day 7 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | All Subjects (Safety Set) |
---|---|
Arm/Group Description | All subjects from >=1 month to <=17 years |
Measure Participants | 45 |
Geometric Mean (Geometric Coefficient of Variation) [μg/mL] |
258.4
(44.6)
|
Title | Plasma Ctrough Values for SPM 12809 at Day 28 |
---|---|
Description | 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. |
Time Frame | Day 28 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | All Subjects (Safety Set) |
---|---|
Arm/Group Description | All subjects from >=1 month to <=17 years |
Measure Participants | 6 |
Geometric Mean (Geometric Coefficient of Variation) [μg/mL] |
754.9
(21.1)
|
Title | Plasma Ctrough Values for SPM 12809 at Day 35 |
---|---|
Description | 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. |
Time Frame | Day 35 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | All Subjects (Safety Set) |
---|---|
Arm/Group Description | All subjects from >=1 month to <=17 years |
Measure Participants | 5 |
Geometric Mean (Geometric Coefficient of Variation) [μg/mL] |
955.1
(24.7)
|
Title | Plasma Ctrough Values for SPM 12809 at Day 42 |
---|---|
Description | 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. |
Time Frame | Day 42 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | All Subjects (Safety Set) |
---|---|
Arm/Group Description | All subjects from >=1 month to <=17 years |
Measure Participants | 14 |
Geometric Mean (Geometric Coefficient of Variation) [μg/mL] |
1725.8
(39.4)
|
Adverse Events
Time Frame | 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. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847. | |||||
Arm/Group Title | >=1 Month to <4 Years (Safety Set) | >=4 Years to <12 Years (Safety Set) | >=12 Years to <=17 Years (Safety Set) | |||
Arm/Group Description | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment | |||
All Cause Mortality |
||||||
>=1 Month to <4 Years (Safety Set) | >=4 Years to <12 Years (Safety Set) | >=12 Years to <=17 Years (Safety Set) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
>=1 Month to <4 Years (Safety Set) | >=4 Years to <12 Years (Safety Set) | >=12 Years to <=17 Years (Safety Set) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/15 (20%) | 3/23 (13%) | 0/9 (0%) | |||
Gastrointestinal disorders | ||||||
Gastrointestinal inflammation | 0/15 (0%) | 0 | 1/23 (4.3%) | 1 | 0/9 (0%) | 0 |
Infections and infestations | ||||||
Pneumonia viral | 1/15 (6.7%) | 1 | 0/23 (0%) | 0 | 0/9 (0%) | 0 |
Viral upper respiratory tract infection | 0/15 (0%) | 0 | 1/23 (4.3%) | 1 | 0/9 (0%) | 0 |
Metabolism and nutrition disorders | ||||||
Dehydration | 1/15 (6.7%) | 1 | 0/23 (0%) | 0 | 0/9 (0%) | 0 |
Nervous system disorders | ||||||
Status epilepticus | 2/15 (13.3%) | 2 | 1/23 (4.3%) | 1 | 0/9 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
>=1 Month to <4 Years (Safety Set) | >=4 Years to <12 Years (Safety Set) | >=12 Years to <=17 Years (Safety Set) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 11/15 (73.3%) | 16/23 (69.6%) | 7/9 (77.8%) | |||
Gastrointestinal disorders | ||||||
Vomiting | 1/15 (6.7%) | 3 | 7/23 (30.4%) | 7 | 2/9 (22.2%) | 2 |
Diarrhoea | 2/15 (13.3%) | 2 | 4/23 (17.4%) | 7 | 1/9 (11.1%) | 1 |
Constipation | 1/15 (6.7%) | 1 | 1/23 (4.3%) | 1 | 1/9 (11.1%) | 1 |
General disorders | ||||||
Irritability | 3/15 (20%) | 3 | 1/23 (4.3%) | 1 | 1/9 (11.1%) | 1 |
Pyrexia | 2/15 (13.3%) | 2 | 3/23 (13%) | 4 | 0/9 (0%) | 0 |
Gait disturbance | 0/15 (0%) | 0 | 2/23 (8.7%) | 2 | 1/9 (11.1%) | 1 |
Infections and infestations | ||||||
Otitis media | 0/15 (0%) | 0 | 3/23 (13%) | 3 | 0/9 (0%) | 0 |
Pharyngotonsillitis | 3/15 (20%) | 3 | 0/23 (0%) | 0 | 0/9 (0%) | 0 |
Nervous system disorders | ||||||
Somnolence | 2/15 (13.3%) | 2 | 3/23 (13%) | 3 | 1/9 (11.1%) | 1 |
Dizziness | 0/15 (0%) | 0 | 3/23 (13%) | 4 | 2/9 (22.2%) | 2 |
Balance disorder | 0/15 (0%) | 0 | 1/23 (4.3%) | 2 | 2/9 (22.2%) | 2 |
Skin and subcutaneous tissue disorders | ||||||
Rash | 1/15 (6.7%) | 1 | 1/23 (4.3%) | 1 | 2/9 (22.2%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Study Director |
---|---|
Organization | UCB |
Phone | +1877 822 9493 |
- SP0847
- 2011-001558-27