A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures

Sponsor
UCB Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT00938431
Collaborator
(none)
47
21
5
57
2.2
0

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

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of Lacosamide (LCM) Oral Solution (Syrup) As Adjunctive Therapy In Children With Partial-Onset Seizures
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Aug 1, 2014

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:
  • Vimpat
  • 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:
  • Vimpat
  • 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:
  • Vimpat
  • 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:
  • Vimpat
  • 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:
  • Vimpat
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks) [13 weeks]

    Secondary Outcome Measures

    1. Change in Seizure Frequency From Baseline to End of Treatment [From Baseline to End of Treatment (approximately 13 weeks)]

    2. 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

    3. 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

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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.

    10. 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.

    11. 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

    Ages Eligible for Study:
    1 Month to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    UCB Pharma
    ClinicalTrials.gov Identifier:
    NCT00938431
    Other Study ID Numbers:
    • SP0847
    • 2011-001558-27
    First Posted:
    Jul 13, 2009
    Last Update Posted:
    Mar 19, 2019
    Last Verified:
    Jul 1, 2017
    Keywords provided by UCB Pharma
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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%
    2. Secondary Outcome
    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)
    3. Secondary Outcome
    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%
    4. Secondary Outcome
    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%
    5. Secondary Outcome
    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)
    6. Secondary Outcome
    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)
    7. Secondary Outcome
    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)
    8. Secondary Outcome
    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)
    9. Secondary Outcome
    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)
    10. Secondary Outcome
    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)
    11. Secondary Outcome
    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)
    12. Secondary Outcome
    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

    [Not Specified]

    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
    Email
    Responsible Party:
    UCB Pharma
    ClinicalTrials.gov Identifier:
    NCT00938431
    Other Study ID Numbers:
    • SP0847
    • 2011-001558-27
    First Posted:
    Jul 13, 2009
    Last Update Posted:
    Mar 19, 2019
    Last Verified:
    Jul 1, 2017