A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
2 other identifiers
interventional
47
3 countries
21
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2009
Longer than P75 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
December 15, 2015
CompletedMarch 19, 2019
July 1, 2017
4.8 years
July 2, 2009
June 29, 2015
March 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)
13 weeks
Secondary Outcomes (11)
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
Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination
Visit 5 (Day 27/28) or Early Termination
Plasma Ctrough Values for Lacosamide at Day 7
Day 7
Plasma Ctrough Values for Lacosamide at Day 28
Day 28
- +6 more secondary outcomes
Study Arms (5)
Lacosamide - Age 5 - 11 years
EXPERIMENTALCohort 1 (Age 5 - 11 years); up to 8 mg/kg/day
Lacosamide - (Age 12 - 17 years)
EXPERIMENTALCohort 2 (Age 12 - 17 years); 12 mg/kg/day.
Lacosamide (Age 2 - 4 years)
EXPERIMENTALCohort 3 (Age 2 - 4 years); 12 mg/kg/day.
Lacosamide (Age 5 - 11 years)
EXPERIMENTALCohort 4 (Age 5 - 11 years); 12 mg/kg/day.
Lacosamide (Age 1 month - < 2 years)
EXPERIMENTALCohort 5 (Age 1 month to \< 2 years); 12 mg/kg/day
Interventions
Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (21)
025
Sacramento, California, United States
002
Washington D.C., District of Columbia, United States
012
Tampa, Florida, United States
019
Wellington, Florida, United States
006
Saint Paul, Minnesota, United States
008
Kansas City, Missouri, United States
015
New Brunswick, New Jersey, United States
005
Durham, North Carolina, United States
001
Philadelphia, Pennsylvania, United States
016
Pittsburgh, Pennsylvania, United States
004
Nashville, Tennessee, United States
026
Austin, Texas, United States
022
Houston, Texas, United States
020
Norfolk, Virginia, United States
201
Brussels, Belgium
200
Edegem, Belgium
202
Leuven, Belgium
101
Culiacán, Mexico
104
Guadalajara, Mexico
105
Monterrey, Mexico
103
San Luis Potosí City, Mexico
Related Publications (1)
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.
PMID: 30427550RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
July 2, 2009
First Posted
July 13, 2009
Study Start
November 1, 2009
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
March 19, 2019
Results First Posted
December 15, 2015
Record last verified: 2017-07