Study to Investigate Lacosamide as Add-on Therapy in Subj... | NCT01921205

ID	Type	Description	Link
2012-004996-38	EudraCT Number

Label	Type	Description	Intervention Names
Lacosamide	Experimental		Drug: Lacosamide
Placebo	Placebo Comparator		Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Lacosamide	Drug	Subjects <30 kg (LCM oral solution): 4 mg/kg - 6 mg/kg BID ( 8mg/kg/day - 12 mg/kg/day) Subjects ≥30 kg to <50 kg (LCM oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day) Subjects ≥50 kg (LCM tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)

Measure	Description	Time Frame
Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period	The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.	Baseline to Week 16 (or last value on treatment)

Measure	Description	Time Frame
Proportion of Responders Where a Responder is Defined as a Participant With >= 50% Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period	Proportion of responders is presented as percentage of participants. A responder is a subject experiencing a 50 % or greater reduction in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors
Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator
Subject is male or female from ≥4 years to <17 years of age
Subject has a diagnosis of Epilepsy with partial-onset seizures. The results of ≥1 prior electroencephalogram (EEG) AND 1 prior magnetic resonance imaging/computerized tomography scan should be consistent with the above diagnosis
Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment (in the opinion of the investigator) with ≥2 Anti-Epileptic Drugs (AEDs) (concurrently or sequentially)
Subject must have been observed to have on average ≥2 partial onset seizures per 28 days with seizure free phase no longer than 21 days in the 8 week period prior to entry into the Baseline Period. During this study, subjects must have reported ≥2 partial onset seizures during the 8 week prospective Baseline Period to be eligible for randomization at Visit 2. (Note: In the case of simple partial onset seizures, only those seizures with motor signs will be counted towards meeting the inclusion criterion.)
Subject is on a stable dosage regimen of 1 to ≤3 AEDs. The daily dosage regimen of concomitant AED therapy must be kept constant for a period of ≥4 weeks prior to the Baseline Period
Vagal nerve stimulation (VNS) is allowed and will not be counted as a concomitant AED. The VNS device must be implanted for ≥6 months before Visit 1, and the device settings must be stable for ≥4 weeks before Visit 1 and be kept stable during the Baseline Period. Use of the VNS device magnet is allowed

Exclusion Criteria:

Subject has previously participated in this study or subject has been assigned to Lacosamide (LCM) in a previous LCM study
Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within ≤2 months of Visit 1 or is currently participating in another study of an IMP or a medical device
Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
Subject ≥6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C SSRS) at Screening
Subject has a known hypersensitivity to any component of the IMP or has ever received LCM
Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception (according to International Conference on Harmonisation [ICH] guidance defined as those that result in a failure rate of less than 1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study. Female subject of childbearing potential taking enzyme inducing antiepileptic drugs (EI AEDs: carbamazepine, phenytoin, barbiturates, primidone, topiramate, oxcarbazepine) who is not surgically sterile or does not practice 1 highly effective method of contraception according to the WHO recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices, combined injectables, and progestogen implants) with administration of EI AEDs OR does not practice 2 combined methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study
Subject has a medical condition that could be expected in the opinion of the investigator to interfere with drug absorption, distribution, metabolism, or excretion
Subject has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to other unprovoked seizures is not exclusionary
Subject is on a ketogenic or other specialized diet. If the subject was on a specialized diet in the past, they must be off the diet for ≥2 months prior to the Baseline Period
Subject has an alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin level ≥2 times the upper limit of normal (ULN), or creatinine clearance less than 30 mL/min
Subject has a clinically relevant ECG abnormality, in the opinion of the investigator (eg, second or third degree heart block at rest or a corrected QT interval [QTc] greater than 450 ms)
Subject has hemodynamically significant congenital heart disease
Subject has an arrhythmic heart condition requiring medical therapy
Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias
Subject has nonepileptic events that could be confused with seizures
Subject has a current diagnosis of Lennox-Gastaut syndrome, primary generalized epilepsy, mixed seizure disorder (partial and primarily generalized seizures), or purely nocturnal seizures
Subject has a history of convulsive status epilepticus ≤2 months prior to the Baseline Period
Subject has been treated with vigabatrin and experienced any vision loss. Subjects who have received vigabatrin in the past must have documentation of an assessment for vision loss prior to study entry or documentation of why visual field testing cannot be performed
Subject has been treated with felbamate and has experienced any serious toxicity issues (defined as liver failure, aplastic anemia) with this treatment. Subjects treated with felbamate for <12 months are excluded. Note: any subject who has been treated with felbamate for ≥12 months and has not experienced serious toxicity issues is eligible
Subject has a medically documented history of alcohol or drug abuse
Subject has a known cardiac sodium channelopathy, such as Brugada syndrome
Subject has an acute or sub acutely progressive central nervous system disease. Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease (malignant brain tumor or Rasmussen Syndrome)

Name	Affiliation	Role
UCB Cares	+1 877 822 9493	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
127		Boulder	Colorado		United States
105

PubMed Identifier	Type	Citation	Retractions
34033237	Derived	Johnson ME, McClung C, Bozorg AM. Analyses of seizure responses supportive of a novel trial design to assess efficacy of antiepileptic drugs in infants and young children with epilepsy: Post hoc analyses of pediatric levetiracetam and lacosamide trials. Epilepsia Open. 2021 Jun;6(2):359-368. doi: 10.1002/epi4.12482. Epub 2021 May 3.
33998660

Label	URL
FDA Safety Alerts and Recalls	View source

ID	Title	Description
FG000	Placebo	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
FG001	Lacosamide

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Feb 9, 2017	Jan 17, 2018

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

Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period

The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.

The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with available data were included in this analysis.

Posted

Median

Full Range

Seizures per 28 days

Baseline to Week 16 (or last value on treatment)

ID	Title	Description
OG000	Placebo (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
OG001	Lacosamide (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

Units	Counts
Participants	OG000168 OG001170

Title

Denominators

Categories

Title	Measurements
	OG000-1.55(-318.7 to 690.0) OG001-3.05(-302.9 to 210.4)

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		ANCOVA	Seizure frequency (log transformed) is analyzed using analysis of covariance with terms for treatment, pooled center and Baseline seizure frequency.	=0.0003		Percent reduction over Placebo	31.72			2-Sided	95	16.342	44.277			Percent reduction over placebo is estimated as 100 x (1-exp[LSMLacosamide-LSMPlacebo]). Where LSM is Least Square Mean.		Superiority

Secondary

Proportion of Responders Where a Responder is Defined as a Participant With >= 50% Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period

Proportion of responders is presented as percentage of participants. A responder is a subject experiencing a 50 % or greater reduction in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period.

Posted

Number

percentage of participants

Baseline to Week 16 (or last value on treatment)

ID	Title	Description
OG000	Placebo (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
OG001	Lacosamide (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

Secondary

Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period

Proportion of subjects is presented as percentage of participants. A >=25%-<50% response in the Maintenance Period is defined as >=25% to <50% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A >=50%-<=75% response in the Maintenance Period is defined as >=50% to <=75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A 75% response in the Maintenance Period is defined as >75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period.

Posted

Number

percentage of participants

Baseline to Week 16 (or last value on treatment)

ID	Title	Description
OG000	Placebo (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
OG001	Lacosamide (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

Secondary

Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)

The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.

Posted

Median

Full Range

Seizures per 28 days

Baseline to Week 16 (or last value on treatment)

ID	Title	Description
OG000	Placebo (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
OG001	Lacosamide (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

Secondary

Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)

Proportion of subjects is presented as percentage of participants. A >=25%-<50% response in the Treatment Period is defined as >=25% to <50% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A >=50%-<=75% response in the Treatment Period is defined as >=50% to <=75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A 75% response in the Treatment Period is defined as >75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period.

Posted

Number

percentage of participants

Baseline to Week 16 (or last value on treatment)

ID	Title	Description
OG000	Placebo (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
OG001	Lacosamide (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

Secondary

Proportion of Subjects Experiencing no Change in Partial Onset Seizure Frequency (Between <25 % Reduction and <25 % Increase) Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)

Proportion of subjects is presented as percentage of participants. No change is defined as between <25% reduction and <25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise not between <25% reduction and <25% increase is defined as a change.

Posted

Number

percentage of participants

Baseline to Week 16 (or last value on treatment)

ID	Title	Description
OG000	Placebo (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
OG001	Lacosamide (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

Secondary

Proportion of Subjects Experiencing an Increase in Partial Onset Seizure Frequency Per 28 Days of >=25 % From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)

Proportion of subjects is presented as percentage of participants. An increase is defined as a >=25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise <25% increase is defined as no increase.

Posted

Number

percentage of participants

Baseline to Week 16 (or last value on treatment)

ID	Title	Description
OG000	Placebo (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
OG001	Lacosamide (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

Secondary

Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures

The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.

Posted

Median

Full Range

Seizures per 28 days

Baseline to Week 16 (or last value on treatment)

ID	Title	Description
OG000	Placebo (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
OG001	Lacosamide (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

Secondary

Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures

The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.

Posted

Median

Full Range

Seizures per 28 days

Baseline to Week 16 (or last value on treatment)

ID	Title	Description
OG000	Placebo (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
OG001	Lacosamide (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

Secondary

Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures

The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.

Posted

Median

Full Range

Seizures per 28 days

Baseline to Week 16 (or last value on treatment)

ID	Title	Description
OG000	Placebo (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
OG001	Lacosamide (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

Secondary

Proportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period

The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded.

Percentages are based on the number of subjects in the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects who completed the Maintenance Period have been included in this analysis.

Posted

Mean

Standard Deviation

days

Week 7 to Week 16

ID	Title	Description
OG000	Placebo (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
OG001	Lacosamide (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

Secondary

Proportion of Subjects Who Achieved "Seizure Free" Status (Yes/no) for Subjects Who Completed the Maintenance Period

Posted

Number

percentage of participants

Week 7 to Week 16

ID	Title	Description
OG000	Placebo (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
OG001	Lacosamide (FAS)	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradycardia	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected172 at risk EG0011 events1 affected171 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected172 at risk EG0010 events0 affected171 at risk
Vomiting	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events1 affected172 at risk EG0011 events1 affected171 at risk
Constipation	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected172 at risk EG0010 events0 affected171 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected172 at risk EG0011 events1 affected171 at risk
Hepatitis	Hepatobiliary disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected172 at risk EG0010 events0 affected171 at risk
Pneumonia	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected172 at risk EG0010 events0 affected171 at risk
Urinary tract infection	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected172 at risk EG0011 events1 affected171 at risk
Bronchitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected172 at risk EG0011 events1 affected171 at risk
Bronchopneumonia	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected172 at risk EG0011 events1 affected171 at risk
Dengue fever	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected172 at risk EG0011 events1 affected171 at risk
Gastroenteritis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected172 at risk EG0010 events0 affected171 at risk
Respiratory tract infection	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected172 at risk EG0010 events0 affected171 at risk
Tonsillitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected172 at risk EG0010 events0 affected171 at risk
Postoperative respiratory distress	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected172 at risk EG0010 events0 affected171 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected172 at risk EG0012 events1 affected171 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected172 at risk EG0010 events0 affected171 at risk
Convulsion	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0005 events4 affected172 at risk EG0012 events2 affected171 at risk
Dystonia	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected172 at risk EG0010 events0 affected171 at risk
Partial seizures	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected172 at risk EG0014 events1 affected171 at risk
Syncope	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected172 at risk EG0012 events1 affected171 at risk
Emotional disorder of childhood	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected172 at risk EG0010 events0 affected171 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected172 at risk EG0010 events0 affected171 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG00015 events11 affected172 at risk EG00122 events17 affected171 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG00013 events9 affected172 at risk EG00115 events8 affected171 at risk
Pyrexia	General disorders	MedDRA16.1	Non-systematic Assessment	EG00011 events10 affected172 at risk EG00121 events17 affected171 at risk
Nasopharyngitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG00010 events10 affected172 at risk EG00129 events20 affected171 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG00014 events10 affected172 at risk EG00113 events10 affected171 at risk
Pharyngitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0005 events5 affected172 at risk EG00113 events10 affected171 at risk
Somnolence	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00014 events11 affected172 at risk EG00142 events28 affected171 at risk
Dizziness	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00014 events13 affected172 at risk EG00126 events18 affected171 at risk
Headache	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00025 events15 affected172 at risk EG00119 events14 affected171 at risk

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

ID	Title	Description
BG000	Placebo	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
BG001	Lacosamide	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
BG002	Total Title

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.	0	172	13	172	61	172
EG001	Lacosamide	This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.	0	171	11	171	85	171