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: August 27, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the safety and pharmacokinetics of LCM syrup in children ages 1 month-17 years with uncontrolled partial seizures when added to 1 to 3 other antiepileptic drugs (AEDs) seizure medications.


Condition Intervention Phase
Epilepsy
Drug: Lacosamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Mean LCM plasma concentration at Visit 5 (Day 27/28) or Early Termination [ Time Frame: Visit 5 (Day 27/28) or Early Termination ] [ Designated as safety issue: No ]
  • Mean SPM 12809 plasma concentration at Visit 5 (Day 27/28) or Early Termination [ Time Frame: Visit 5 (Day 27/28) or Early Termination ] [ Designated as safety issue: No ]
  • Change in seizure frequency from Baseline to End of Treatment [ Time Frame: From Baseline to End of Treatment ] [ Designated as safety issue: No ]

    For assessment of the Clinical Global Impression of Change, the investigator should provide 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

  • Mean 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) should provide 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 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

  • Mean in 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 ]

Enrollment: 47
Study Start Date: October 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide - Age 5 - 11 years (up to 8 mg/kg/day))
Cohort 1 (Age 5 - 11 years)
Drug: Lacosamide

Lacosamide oral solution (syrup) 8 mg/kg/day, 10 mg/kg/day, and/or 12 mg/kg/day.

Depending on the target dose, treatment duration can last up to 42 days.

Other Name: Vimpat®
Experimental: Lacosamide - (Age 12 - 17 years)
Cohort 2 (Age 12 - 17 years); 8 mg/kg/day, 10 mg/kg/day, or 12 mg/kg/day.
Drug: Lacosamide

Lacosamide oral solution (syrup) 8 mg/kg/day, 10 mg/kg/day, and/or 12 mg/kg/day.

Depending on the target dose, treatment duration can last up to 42 days.

Other Name: Vimpat®
Experimental: Lacosamide (Age 2 - 4 years)
Cohort 3 (Age 2 - 4 years); 8 mg/kg/day, 10 mg/kg/day, or 12 mg/kg/day.
Drug: Lacosamide

Lacosamide oral solution (syrup) 8 mg/kg/day, 10 mg/kg/day, and/or 12 mg/kg/day.

Depending on the target dose, treatment duration can last up to 42 days.

Other Name: Vimpat®
Experimental: Lacosamide (Age 5 - 11 years)
Cohort 4 (Age 5 - 11 years); 10 mg/kg/day or 12 mg/kg/day.
Drug: Lacosamide

Lacosamide oral solution (syrup) 8 mg/kg/day, 10 mg/kg/day, and/or 12 mg/kg/day.

Depending on the target dose, treatment duration can last up to 42 days.

Other Name: Vimpat®
Experimental: Lacosamide (Age 1 month - < 2 years)
Cohort 5 ((Age 1 month - < 2 years); 8 mg/kg/day, 10 mg/kg/day, or 12 mg/kg/day
Drug: Lacosamide

Lacosamide oral solution (syrup) 8 mg/kg/day, 10 mg/kg/day, and/or 12 mg/kg/day.

Depending on the target dose, treatment duration can last up to 42 days.

Other Name: Vimpat®

Detailed Description:

Six subjects aged 5-11 will initially be enrolled at the 8 mg/kg/day dose level. Upon completion of the trial for these subjects, pharmacokinetic and safety data will be analyzed to determine the target dose for the remaining subjects (either 8, 10 or 12 mg/kg/day). Depending on the selected target dose, different age-based Cohorts of subjects will be enrolled. LCM will be increased 2 mg/kg/day per week until the target dose or maximum dose able to be tolerated is achieved.

  Eligibility

Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938431

Locations
United States, California
025
Sacramento, California, United States
United States, District of Columbia
002
Washington, District of Columbia, United States
United States, Florida
012
Tampa, Florida, United States
019
Wellington, Florida, United States
United States, Minnesota
006
St Paul, Minnesota, United States
United States, Missouri
008
Kansas City, Missouri, United States
United States, New Jersey
015
New Brunswick, New Jersey, United States
United States, North Carolina
005
Durham, North Carolina, United States
United States, Pennsylvania
001
Philadelphia, Pennsylvania, United States
016
Pittsburgh, Pennsylvania, United States
United States, Tennessee
004
Nashville, Tennessee, United States
United States, Texas
026
Austin, Texas, United States
022
Houston, Texas, United States
United States, Virginia
020
Norfolk, Virginia, United States
Belgium
201
Brussels, Belgium
200
Edegem, Belgium
202
Leuven, Belgium
Mexico
101
Culiacan, Mexico
104
Guadalajara, Mexico
105
Monterrey, Mexico
103
San Luis Potosi, Mexico
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00938431     History of Changes
Other Study ID Numbers: SP847, 2011-001558-27
Study First Received: July 2, 2009
Last Updated: August 27, 2014
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by UCB Pharma:
Lacosamide
Vimpat®
Children
Epilepsy
Seizures
Anti-epileptic

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014