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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00938431
First received: July 2, 2009
Last updated: November 10, 2015
Last verified: November 2015

July 2, 2009
November 10, 2015
November 2009
August 2014   (final data collection date for primary outcome measure)
Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Number of subjects that report at least one treatment-emergent adverse event [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00938431 on ClinicalTrials.gov Archive Site
  • Change in Seizure Frequency From Baseline to End of Treatment [ Time Frame: From Baseline to End of Treatment (approximately 13 weeks) ] [ Designated as safety issue: No ]
  • Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination [ Time Frame: Visit 5 (Day 27/28) or Early Termination ] [ Designated as safety issue: No ]

    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:

    1. Very much improved
    2. Much improved
    3. Minimally improved
    4. No change
    5. Minimally worse
    6. Much worse
    7. Very much worse
  • Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination [ Time Frame: Visit 5 (Day 27/28) or Early Termination ] [ Designated as safety issue: No ]

    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:

    1. Very much improved
    2. Much improved
    3. Minimally improved
    4. No Change
    5. Minimally worse
    6. Much worse
    7. Very much worse
  • Plasma Ctrough Values for Lacosamide at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 35 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 42 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 35 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 42 ] [ Designated as safety issue: No ]

    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.

  • Mean LCM plasma concentration [ Time Frame: Pre-dose (-1 to 0 hours) ] [ Designated as safety issue: No ]
  • Mean LCM plasma concentration [ Time Frame: 18-42 minutes post-dose ] [ Designated as safety issue: No ]
  • Mean LCM plasma concentration [ Time Frame: 48-72 minutes post-dose ] [ Designated as safety issue: No ]
  • Mean LCM plasma concentration [ Time Frame: 90 to 150 minutes post-dose ] [ Designated as safety issue: No ]
  • Mean LCM plasma concentration [ Time Frame: 210 to 270 minutes post-dose ] [ Designated as safety issue: No ]
  • Mean LCM plasma concentration [ Time Frame: 6 to 9 hours post-dose ] [ Designated as safety issue: No ]
  • Mean LCM plasma concentration [ Time Frame: 11 to 12 hours post-dose ] [ Designated as safety issue: No ]
  • Mean SPM 12809 plasma concentration [ Time Frame: Pre-dose (-1 to 0 hours) ] [ Designated as safety issue: No ]
  • Mean SPM 12809 plasma concentration [ Time Frame: 18-42 minutes post-dose ] [ Designated as safety issue: No ]
  • Mean SPM 12809 plasma concentration [ Time Frame: 48-72 minutes post-dose ] [ Designated as safety issue: No ]
  • Mean SPM 12809 plasma concentration [ Time Frame: 90 to 150 minutes post-dose ] [ Designated as safety issue: No ]
  • Mean SPM 12809 plasma concentration [ Time Frame: 210 to 270 minutes post-dose ] [ Designated as safety issue: No ]
  • Mean SPM 12809 plasma concentration [ Time Frame: 6 to 9 hours post-dose ] [ Designated as safety issue: No ]
  • Mean SPM 12809 plasma concentration [ Time Frame: 11 to 12 hours post-dose ] [ Designated as safety issue: No ]
  • Change in seizure frequency [ Time Frame: Baseline to Withdrawal/End of Treatment (Week 4, 5, or 6 depending on maximum recommended dose) ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression of Change score [ Time Frame: Early Termination Visit/End of Treatment (Week 4 for maximum dose of 8mg/kg/day, Week 5 for maximum dose of 10mg/kg/day or Week 6 for maximum dose of 12mg/kg/day) ] [ Designated as safety issue: No ]
  • Change in Caregiver Global Impression of Change [ Time Frame: Early Termination Visit/End of Treatment (Week 4 for maximum dose of 8mg/kg/day, Week 5 for maximum dose of 10mg/kg/day or Week 6 for maximum dose of 12mg/kg/day) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
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
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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
Drug: Lacosamide
Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL
Other Name: Vimpat
  • Experimental: Lacosamide - Age 5 - 11 years
    Cohort 1 (Age 5 - 11 years); up to 8 mg/kg/day
    Intervention: Drug: Lacosamide
  • Experimental: Lacosamide - (Age 12 - 17 years)
    Cohort 2 (Age 12 - 17 years); 12 mg/kg/day.
    Intervention: Drug: Lacosamide
  • Experimental: Lacosamide (Age 2 - 4 years)
    Cohort 3 (Age 2 - 4 years); 12 mg/kg/day.
    Intervention: Drug: Lacosamide
  • Experimental: Lacosamide (Age 5 - 11 years)
    Cohort 4 (Age 5 - 11 years); 12 mg/kg/day.
    Intervention: Drug: Lacosamide
  • Experimental: Lacosamide (Age 1 month - < 2 years)
    Cohort 5 (Age 1 month to < 2 years); 12 mg/kg/day
    Intervention: Drug: Lacosamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
1 Month to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Mexico
 
NCT00938431
SP0847, 2011-001558-27
No
Not Provided
Not Provided
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP