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

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ClinicalTrials.gov Identifier: NCT00938431
Recruitment Status : Completed
First Posted : July 13, 2009
Results First Posted : December 15, 2015
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE July 2, 2009
First Posted Date  ICMJE July 13, 2009
Results First Submitted Date  ICMJE June 29, 2015
Results First Posted Date  ICMJE December 15, 2015
Last Update Posted Date March 19, 2019
Study Start Date  ICMJE November 2009
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks) [ Time Frame: 13 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2009)
Number of subjects that report at least one treatment-emergent adverse event [ Time Frame: 13 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • Change in Seizure Frequency From Baseline to End of Treatment [ Time Frame: From Baseline to End of Treatment (approximately 13 weeks) ]
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2009)
  • Mean LCM plasma concentration [ Time Frame: Pre-dose (-1 to 0 hours) ]
  • Mean LCM plasma concentration [ Time Frame: 18-42 minutes post-dose ]
  • Mean LCM plasma concentration [ Time Frame: 48-72 minutes post-dose ]
  • Mean LCM plasma concentration [ Time Frame: 90 to 150 minutes post-dose ]
  • Mean LCM plasma concentration [ Time Frame: 210 to 270 minutes post-dose ]
  • Mean LCM plasma concentration [ Time Frame: 6 to 9 hours post-dose ]
  • Mean LCM plasma concentration [ Time Frame: 11 to 12 hours post-dose ]
  • Mean SPM 12809 plasma concentration [ Time Frame: Pre-dose (-1 to 0 hours) ]
  • Mean SPM 12809 plasma concentration [ Time Frame: 18-42 minutes post-dose ]
  • Mean SPM 12809 plasma concentration [ Time Frame: 48-72 minutes post-dose ]
  • Mean SPM 12809 plasma concentration [ Time Frame: 90 to 150 minutes post-dose ]
  • Mean SPM 12809 plasma concentration [ Time Frame: 210 to 270 minutes post-dose ]
  • Mean SPM 12809 plasma concentration [ Time Frame: 6 to 9 hours post-dose ]
  • Mean SPM 12809 plasma concentration [ Time Frame: 11 to 12 hours post-dose ]
  • Change in seizure frequency [ Time Frame: Baseline to Withdrawal/End of Treatment (Week 4, 5, or 6 depending on maximum recommended dose) ]
  • 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) ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
Official Title  ICMJE 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
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Drug: Lacosamide
Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL
Other Name: Vimpat
Study Arms  ICMJE
  • 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
Publications * Winkler J, Schoemaker R, Stockis A. Population Pharmacokinetics of Adjunctive Lacosamide in Pediatric Patients With Epilepsy. J Clin Pharmacol. 2019 Apr;59(4):541-547. doi: 10.1002/jcph.1340. Epub 2018 Nov 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2014)
47
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2009)
35
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00938431
Other Study ID Numbers  ICMJE SP0847
2011-001558-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date July 2017

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