Phase 2
Completed N=47
A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
Source: ClinicalTrials.gov NCT00938431 ↗Enrolled (actual)
47
Serious AEs
12.8%
Results posted
Dec 2015
Primary outcomePrimary: Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks) — 14; 19; 9 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks) |
14; 19; 9 | — |
| SECONDARY Change in Seizure Frequency From Baseline to End of Treatment |
18.94; 18.38; 34.59 | — |
| SECONDARY Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination |
3; 2; 0; 7; 8; 4 | — |
| SECONDARY Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination |
2; 2; 0; 6; 7; 7 | — |
| SECONDARY Plasma Ctrough Values for Lacosamide at Day 7 |
839.9 | — |
| SECONDARY Plasma Ctrough Values for Lacosamide at Day 28 |
3886.0 | — |
| SECONDARY Plasma Ctrough Values for Lacosamide at Day 35 |
4033.8 | — |
| SECONDARY Plasma Ctrough Values for Lacosamide at Day 42 |
4169.5 | — |
| SECONDARY Plasma Ctrough Values for SPM 12809 at Day 7 |
258.4 | — |
| SECONDARY Plasma Ctrough Values for SPM 12809 at Day 28 |
754.9 | — |
| SECONDARY Plasma Ctrough Values for SPM 12809 at Day 35 |
955.1 | — |
| SECONDARY Plasma Ctrough Values for SPM 12809 at Day 42 |
1725.8 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00938431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.