A Study to Assess the Safety and Efficacy of Lacosamide V... | NCT02408523

NCT02408523

ID	Type	Description	Link
2011-003100-21	EudraCT Number

Status Module

Name	Class
Pharmaceutical Research Associates	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lacosamide	Experimental	Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day are allowed. Maximal dose 400 mg/day for adult subjects and pediatric subjects >= 50 kg. Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric subjects < 30 kg.) Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric subjects 30 kg to < 50 kg.)	Drug: Lacosamide Tablet Drug: Lasosamide Oral Solution
Placebo	Placebo Comparator	Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day are allowed. Maximal dose 400mg/day for adult subjects and pediatric subjects >= 50kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric subjects < 30kg.) Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric subjects 30kg to < 50kg.)	Other: Placebo Tablet Other: Placebo Oral Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lacosamide Tablet	Drug	Active Substance: Lacosamide Pharmaceutical Form: Film-coated Tablet Concentration: 50 mg Route of Administration: Oral use	Lacosamide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)	The primary efficacy variable was the time to the second primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio. The indicated measured values are the observed number of events of second PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis. The hazard ratio compares 2 treatment groups for the times to a specified number of events (125) for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio. A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo.	During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)	A seizure-free day from primary generalized tonic clonic seizures (PGTCS) was defined as a day where no PGTCS were reported in the seizure diary and PGTCS were assessed, which was estimated using Kaplan-Meier (KM) methods.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalized tonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981)
Subject has >=3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures
Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed antiepileptic drugs (AEDs) with no benzodiazepine AEDs OR 1 benzodiazepine marketed AED with 1 to 2 non benzodiazepine marketed AEDs for at least 28 days prior to Visit 1 with or without additional concurrent stable vagus nerve stimulation (VNS)
Subjects are required to have had an electroencephalogram (EEG) report consistent with idiopathic generalized epilepsy (eg, generalized 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer

Exclusion Criteria:

Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)
Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
Subject has an active suicidal ideation as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Since Last Visit' version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%)

For randomized subjects with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic case report form (eCRF).

If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the subject must be discussed with the Medical Monitor.

Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation. This includes re-screening.

Name	Affiliation	Role
UCB Cares	+1 844 599 2273 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Sp0982 028		Alabaster	Alabama	35007	United States
Sp0982 005

Label	URL
FDA Safety Alerts and Recalls	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants >= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Mar 28, 2019	Apr 3, 2020

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants >= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg).
BG001	Lacosamide	Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg).
BG002	Total Title

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG00027 BG00128 BG00255
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00027.64± 12.45 BG00127.82± 13.13 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00076 BG00166 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian/Alaskan Native	BG0001 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)

The primary efficacy variable was the time to the second primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio.

The indicated measured values are the observed number of events of second PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis.

The hazard ratio compares 2 treatment groups for the times to a specified number of events (125) for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio.

A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo.

The Full Analysis Set (FAS) was a subset of the Safety Set (SS) that consisted of all study participants with at least 1 seizure diary assessment during the Treatment Period.

1 patient from the Lacosamide (FAS) group was randomized after the 125th event and did not appear in this analysis.

Posted

Number

events

During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

ID	Title	Description
OG000	Placebo (FAS)	Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants >= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg). Participants formed the Full Analysis Set (FAS).
OG001	Lacosamide (FAS)	Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg). Participants formed the FAS.

Units	Counts
Participants	OG000121 OG001118

Title

Denominators

Categories

Title	Measurements
	OG00076 OG00149

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants' Baseline PGTCS frequency and Development from interactive response technology (IRT) (<= 2 per 28 days in the Combined Baseline Period and Pediatric, <= 2 per 28 days in the Combined Baseline Period and Adult, and > 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.	Regression, Cox		<0.001	Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).	Hazard Ratio (HR)	0.540			2-Sided	95	0.377	0.774

Secondary

Percentage of Participants With Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)

A seizure-free day from primary generalized tonic clonic seizures (PGTCS) was defined as a day where no PGTCS were reported in the seizure diary and PGTCS were assessed, which was estimated using Kaplan-Meier (KM) methods.

The Full Analysis Set (FAS) was a subset of the Safety Set (SS) that consisted of all study participants with at least 1 seizure diary assessment during the Treatment Period.

1 patient from the Lacosamide (FAS) group was randomized after the 125th event and did not appear in this analysis.

Posted

Number

95% Confidence Interval

percentage of participants

During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

ID	Title	Description
OG000	Placebo (FAS)	Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants >= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg). Participants formed the Full Analysis Set (FAS).
OG001	Lacosamide (FAS)

Secondary

Time to the First Primary Generalized Tonic Clonic (PGTC) Seizure During the Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)

The secondary efficacy variable was the time to the first primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio.

The indicated measured values are the observed number of events of first PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis.

The hazard ratio compares 2 treatment groups for the times to the number of events for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio.

A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo.

The Full Analysis Set (FAS) was a subset of the Safety Set (SS) that consisted of all study participants with at least 1 seizure diary assessment during the Treatment Period.

1 patient from the Lacosamide (FAS) group was randomized after the 125th event and did not appear in this analysis.

Posted

Number

events

During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

ID	Title	Description
OG000	Placebo (FAS)	Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants >= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg). Participants formed the Full Analysis Set (FAS).

Secondary

Percentage of Participants With at Least One Adverse Event (AE) as Reported Spontaneously by the Subject and/or Caregiver or Observed by the Investigator

An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product (IMP), whether or not related to the IMP.

The Safety Set (SS) was a subset of the Randomized Set (RS) and consisted of all study participants who had been treated with at least 1 dose of study medication, either LCM or Placebo.

Posted

Number

percentage of participants

From Visit 1 (Week -4) to End of Study Period (up to Week 36)

ID	Title	Description
OG000	Placebo (SS)	Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants >= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg). Participants formed the Safety Set (SS).
OG001	Lacosamide (SS)

Secondary

Plasma Concentrations of Lacosamide

Lacosamide plasma concentration was expressed in micrograms per milliliter (μg/mL).

Means and standard deviation (SD) were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint. Values Below Limit of Quantification (BLQ) were replaced by value of 0 in calculations of means and SDs.

The Safety Set (SS) was a subset of the Randomized Set (RS) and consisted of all study participants who had been treated with at least 1 dose of study medication, either LCM or Placebo.

Data not collected from participants in Placebo (SS) Arm/Group.

Posted

Mean

Standard Deviation

ug/mL

During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

ID	Title	Description
OG000	Placebo (SS)	Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants >= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg). Participants formed the Safety Set (SS).
OG001	Lacosamide (SS)	Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg). Participants formed the SS.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo (SS) Treatment Period	Participants received the following treatment during the Treatment Period (Week 0 to Week 24): Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400mg/day for adult and pediatric participants >= 50 kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants < 30 kg). Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg). Participants formed the Safety Set (SS).	121	4	121	41	121
EG001	Lacosamide (SS) Treatment Period	Participants received the following treatment during the Treatment Period (Week 0 to Week 24): Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (>=) 50 kilograms (kg). Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (<) 30 kg). Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg). Participants formed the SS.	121	8	121	60	121
EG002	Placebo (SS) Transition Period	At the end of Visit 10 (Week 24)/ Early Termination (ET), study participants who completed the study may have been eligible to participate in an open-label extension study (EP0012). Study participants who chose to enroll in the open-label extension study proceeded to a blinded 4-week Transition Period. Participants randomized to Placebo in the Treatment Period transitioned to double-blind Lacosamide: Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 100 mg/day until final dose of 400 mg/day at Week 4 for adult and pediatric participants >= 50 kg. Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day at Week 1. Weekly increase in steps of 2 mg/kg/day until final dose of 8 mg/kg/day at Week 4 for pediatric participants < 30 kg and 0 kg to < 50 kg. Participants formed the SS.	108	0	108	27	108
EG003	Lacosamide (SS) Transition Period	At the end of Visit 10 (Week 24)/ Early Termination (ET), study participants who completed the study may have been eligible to participate in an open-label extension study (EP0012). Study participants who chose to enroll in the open-label extension study proceeded to a blinded 4-week Transition Period. Participants randomized to Lacosaminde in the Treatment Period continued to receive double-blind Lacosamide: Lacosamide 50 mg tablets: minim (min) 300 mg/day to maximum (max) 400 mg/day from Week 1 to Week 3 and final dose of 400 mg/day at Week 4 for adult and pediatric participants >= 50 kg. Lacosamide oral solution 10 mg/ml: min 8 mg/kg/day to max 12 mg/kg/day from Week 1 to Week 4 for pediatric participants < 30 kg. Lacosamide oral solution 10 mg/ml: min 6 mg/kg/day to max 8 mg/kg/day from Week 1 to Week 3 and final dose of 8 mg/kg/day at Week 4 for pediatric participants 30 kg to < 50 kg. Participants formed the SS.	101	3	101	5	101
EG004	Placebo (SS) Taper Period	Study participants completing Visit 10 (Week 24) or the ET Visit who chose not to continue in EP0012 must have completed an up to 4 weeks blinded taper followed by the End of Taper Visit. Participants randomized to Placebo in the Treatment Period continued to receive Placebo: Placebo 50 mg tablets: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 100 mg/day until no treatment received for adult and pediatric participants >= 50 kg. Placebo oral solution 10 mg/ml: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 2 mg/kg/day or 3 mg/kg/day until no treatment received for pediatric participants < 30 kg and 0 kg to < 50 kg. Participants formed the SS.	7	0	7	3	7
EG005	Lacosamide (SS) Taper Period	Study participants completing Visit 10 (Week 24) or the ET Visit who chose not to continue in EP0012 must have completed an up to 4 weeks blinded taper followed by the End of Taper Visit. Participants randomized to Lacosamide in the Treatment Period continued to receive Lacosamide: Lacosamide 50 mg tablets: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 100 mg/day until no treatment received for adult and pediatric participants >= 50 kg. Lacosamide oral solution 10 mg/ml: starting with maximum dose achieved during the Treatment Period. Weekly decrease in steps of 2 mg/kg/day or 3 mg/kg/day until no treatment received for pediatric participants < 30 kg and 0 kg to < 50 kg. Participants formed the SS.	9	0	9	2	9
EG006	Placebo (SS) Safety Follow-up Period	There was a 30-day (-1/+3 days) Safety Follow-up Period for study participants who completed the End of Taper Visit. The Safety Follow-up Period consisted of a clinic visit 2 weeks after the End of Taper Visit followed 2 weeks later by a telephone contact (TC). Participants did not receive any treatment during this period. Participants formed the SS.	10	1	10	0	10
EG007	Lacosamide (SS) Safety Follow-up Period	There was a 30-day (-1/+3 days) Safety Follow-up Period for study participants who completed the End of Taper Visit. The Safety Follow-up Period consisted of a clinic visit 2 weeks after the End of Taper Visit followed 2 weeks later by a telephone contact (TC). Participants did not receive any treatment during this period. Participants formed the SS.	11	1	11	0	11

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected121 at risk EG0020 events0 affected108 at risk EG0030 events0 affected101 at risk EG0040 events0 affected7 at risk EG0050 events0 affected9 at risk EG0060 events0 affected10 at risk EG0070 events0 affected11 at risk
Nausea	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected121 at risk EG0020 events0 affected108 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected121 at risk EG0020 events0 affected108 at risk EG003
Asthenia	General disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected121 at risk EG0020 events0 affected108 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected121 at risk EG0020 events0 affected108 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003
Transaminases increased	Investigations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected121 at risk EG0020 events0 affected108 at risk EG003
Liver function test abnormal	Investigations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected121 at risk EG0020 events0 affected108 at risk EG003
Dizziness	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0012 events2 affected121 at risk EG0020 events0 affected108 at risk EG003
Somnolence	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0012 events2 affected121 at risk EG0020 events0 affected108 at risk EG003
Grand mal convulsion	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected121 at risk EG0020 events0 affected108 at risk EG003
Headache	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected121 at risk EG0020 events0 affected108 at risk EG003
Status epilepticus	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected121 at risk EG0020 events0 affected108 at risk EG003
Clonic convulsion	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003
Abortion induced	Surgical and medical procedures	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertigo	Ear and labyrinth disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected121 at risk EG0018 events8 affected121 at risk EG0024 events3 affected108 at risk EG0031 events1 affected101 at risk EG0040 events0 affected7 at risk EG0050 events0 affected9 at risk EG0060 events0 affected10 at risk EG0070 events0 affected11 at risk
Nausea	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0007 events7 affected121 at risk EG00112 events11 affected121 at risk EG0023 events2 affected108 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0003 events1 affected121 at risk EG00110 events7 affected121 at risk EG0025 events3 affected108 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003
Fatigue	General disorders	MedDRA16.1	Non-systematic Assessment	EG0006 events6 affected121 at risk EG0018 events8 affected121 at risk EG0022 events2 affected108 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0004 events4 affected121 at risk EG00112 events8 affected121 at risk EG0022 events2 affected108 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003
Dizziness	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0007 events7 affected121 at risk EG00134 events26 affected121 at risk EG00210 events10 affected108 at risk EG003
Somnolence	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00017 events17 affected121 at risk EG00119 events18 affected121 at risk EG0027 events7 affected108 at risk EG003
Headache	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00013 events12 affected121 at risk EG00118 events16 affected121 at risk EG0025 events5 affected108 at risk EG003
Drooling	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003
Grand mal convulsion	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected121 at risk EG0010 events0 affected121 at risk EG0020 events0 affected108 at risk EG003

Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day were allowed. Maximal dose 400 mg/day for adult and pediatric participants with more or equal than (>=) 50 kilograms (kg).

Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric participants with less than (<) 30 kg).

Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric participants 30 kg to < 50 kg).

Participants formed the FAS.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids