A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment

A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04627285

Enrollment

Registered

2020-11-13

Start date

2020-12-28

Completion date

2025-02-12

Last updated

2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Lacosamide, Vimpat, Epilepsy, Pediatric

Brief summary

The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).

Interventions

DRUGLacosamide

* Pharmaceutical form: Oral-solution * Route of administration: Oral use Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

Healthy volunteers

Inclusion criteria

* Participant is male or female, aged \<6 years at the time of signing the Informed Consent Form (ICF) * Participant has completed participation in NCT01964560 (EP0034) or NCT00938912 (SP848) * Participant is expected to benefit from participation, in the opinion of the Investigator

Exclusion criteria

* Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study * Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol * Participant is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM) * Participant meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for NCT01964560 (EP0034) or NCT00938912 (SP848), or is experiencing an ongoing serious adverse event (SAE) * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)	From visit 1 (Week 0) to the end of study visit (up to Week 214.42)	An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent.
Percentage of Participants Who Withdrew From Study Due to TEAEs	From visit 1 (Week 0) to the end of study visit (up to Week 214.42)	An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent.
Percentage of Participants Who Withdrew From Study Due to Serious Adverse Event (SAEs)	From visit 1 (Week 0) to the end of study visit (up to Week 214.42)	A SAE is defined as results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect, other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. Only participants who discontinued the study due to SAEs are reported.
Modal Daily Dose During the Study	From visit 1 (Week 0) to the end of study visit (up to Week 214.42)	The modal daily LCM dose in milligram per kilogram (mg/kg/day) is defined as the daily Lacosamide dose the participant received for the longest duration in EP0151.
Maximum Daily Dose During the Study	From visit 1 (Week 0) to the end of study visit (up to Week 214.42)	Maximum daily dose is defined as the highest total daily dose a participant received in EP0151.

Countries

Georgia, Hungary, Moldova, Romania, Taiwan, Ukraine

Participant flow

Recruitment details

The study started to enroll participants in December 2020 and concluded in February 2025.

Pre-assignment details

Participants who completed studies EP0034 (NCT01964560) or SP848 (NCT00938912) were offered participation in this study. The Participant Flow refers to the Safety Set (SS).

Participants by arm

Arm	Count
Lacosamide: >=2 to <4 Years Participants aged greater than or equal to (\>=) 2 to less than (\<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.	19
Lacosamide: >=4 to <6 Years Participants aged \>=4 to \<6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.	29
Total	48

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	2
Overall Study	Lost to Follow-up	1	0
Overall Study	Participant left country; aunt informed the site	0	1
Overall Study	Sponsor decision	5	0
Overall Study	Withdrawal by Subject	1	1

Baseline characteristics

Characteristic	Lacosamide: >=2 to <4 Years	Lacosamide: >=4 to <6 Years	Total
Age, Continuous	2.888 years STANDARD_DEVIATION 0.518	5.180 years STANDARD_DEVIATION 0.642	4.273 years STANDARD_DEVIATION 1.277
Age, Customized Greater than or equal to (>=) 24 months to less than (<) 12 years	19 Participants	29 Participants	48 Participants
Race/Ethnicity, Customized Ethnicity Hispanic or Latino	0 Participants	3 Participants	3 Participants
Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino	19 Participants	26 Participants	45 Participants
Race/Ethnicity, Customized Race Asian	1 Participants	1 Participants	2 Participants
Race/Ethnicity, Customized Race White	18 Participants	28 Participants	46 Participants
Sex: Female, Male Female	6 Participants	9 Participants	15 Participants
Sex: Female, Male Male	13 Participants	20 Participants	33 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 19	2 / 29
other Total, other adverse events	5 / 19	4 / 29
serious Total, serious adverse events	2 / 19	5 / 29