Trial Outcomes & Findings for Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures (NCT NCT00520741)

NCT ID: NCT00520741

Last Updated: 2018-07-19

Results Overview

Pre-defined exit criteria: 1. A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase 2. A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase. Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion 3. Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization 4. A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation 5. Status epilepticus, or new onset of serial/cluster seizures

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

426 participants

Primary outcome timeframe

16 Weeks Maintenance Period (approximately 112 days)

Results posted on

2018-07-19

Participant Flow

The study was conducted at 160 sites in the United States of America (USA), Canada, Europe, and Australia.The maximum duration of a subject's trial participation is 30 weeks. The Participant Flow refers to the Safety Set (SS) population which consists of all patients who received at least one dose of study medication.

Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.

Participant milestones

Participant milestones
Measure	Lacosamide 300 mg/Day Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/Day Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Overall Study STARTED	106	319
Overall Study COMPLETED	69	194
Overall Study NOT COMPLETED	37	125

Reasons for withdrawal

Reasons for withdrawal
Measure	Lacosamide 300 mg/Day Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/Day Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Overall Study Adverse Event	16	56
Overall Study Lack of Efficacy	11	30
Overall Study Withdrawal by Subject	0	11
Overall Study Protocol Violation	2	15
Overall Study Unsatisfactory compliance of subject	4	3
Overall Study Lost to Follow-up	4	4
Overall Study Other reasons for premature termination	0	6

Baseline Characteristics

Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lacosamide 300 mg/Day n=106 Participants Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/Day n=319 Participants Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Total n=425 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	99 Participants n=5 Participants	303 Participants n=7 Participants	402 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	41.4 years STANDARD_DEVIATION 14.3 • n=5 Participants	40.4 years STANDARD_DEVIATION 12.5 • n=7 Participants	40.6 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	169 Participants n=7 Participants	219 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	150 Participants n=7 Participants	206 Participants n=5 Participants
Race/Ethnicity, Customized White	91 participants n=5 Participants	246 participants n=7 Participants	337 participants n=5 Participants
Race/Ethnicity, Customized Black	9 participants n=5 Participants	53 participants n=7 Participants	62 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Other	6 participants n=5 Participants	19 participants n=7 Participants	25 participants n=5 Participants
Height	169.72 centimeter STANDARD_DEVIATION 10.69 • n=5 Participants	169.01 centimeter STANDARD_DEVIATION 10.87 • n=7 Participants	169.19 centimeter STANDARD_DEVIATION 10.82 • n=5 Participants
Weight	81.62 kilogram STANDARD_DEVIATION 19.53 • n=5 Participants	82.13 kilogram STANDARD_DEVIATION 21.30 • n=7 Participants	82.00 kilogram STANDARD_DEVIATION 20.85 • n=5 Participants
Body Mass Index (BMI)	28.22 kg/m^2 STANDARD_DEVIATION 5.74 • n=5 Participants	28.67 kg/m^2 STANDARD_DEVIATION 6.64 • n=7 Participants	28.56 kg/m^2 STANDARD_DEVIATION 6.42 • n=5 Participants
Average Baseline Seizure Frequency per 28 days	10.10 seizures/28 days STANDARD_DEVIATION 8.82 • n=5 Participants	10.22 seizures/28 days STANDARD_DEVIATION 8.88 • n=7 Participants	10.19 seizures/28 days STANDARD_DEVIATION 8.86 • n=5 Participants

PRIMARY outcome

Timeframe: 16 Weeks Maintenance Period (approximately 112 days)

Population: The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (ie, entered the Maintenance Phase and took at least 1 dose of Maintenance medication). The primary analysis is only conducted on the Lacosamide 400 mg/day group.

Outcome measures

Outcome measures
Measure	Lacosamide 300 mg/Day Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/Day n=284 Participants Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure.
Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)	—	30.0 percentage of subjects

SECONDARY outcome

Timeframe: 16 Weeks Maintenance Period (approximately 112 days)

Population: The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs). In addition to being a member of FAS, subjects also met at least one of the exit criterion noted under the Primary Outcome Measure.

The time to first occurrence (days) of any exit event was estimated using Kaplan-Meier methods and was based on the time from the start of the Maintenance Phase to the earliest date a subject met an exit criterion. Subjects who discontinued during the Maintenance Phase due to non-exit criteria reasons or who completed the Maintenance Phase before 112 days and did not meet an exit criterion were censored as of the last Maintenance Phase dose date. Subjects completing 112 days in the Maintenance Phase were censored as of Day 112.

Outcome measures

Outcome measures
Measure	Lacosamide 300 mg/Day n=26 Participants Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/Day n=82 Participants Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure.
Time to First Occurrence of Any Exit Event During The Maintenance Period	39 days Full Range 21.2 • Interval 1.0 to 80.0	45.0 days Full Range 24.3 • Interval 3.0 to 102.0

SECONDARY outcome

Timeframe: 16 Weeks Maintenance Period (approximately 112 days)

Population: The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).

Subjects were classified as having an exit event if they experienced at least 1 of the following events during the Maintenance Phase as of Day 112: 1. Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis 2. Withdrawal due to AE with onset during the Maintenance Phase 3. Withdrew prematurely due to lack of efficacy during the Maintenance Phase The date the subject experienced the event was set to the earliest date the subject met an exit criterion or the date of the last Maintenance Phase dose for subjects not meeting an exit criterion but withdrawing due to an AE or lack of efficacy. The secondary analysis is only conducted on the Lacosamide 400 mg/day group.

Outcome measures

Outcome measures
Measure	Lacosamide 300 mg/Day Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/Day n=284 Participants Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure.
Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period	—	32.3 percentage of subjects

SECONDARY outcome

Timeframe: Visit 9 - Visit 12 (approximately 10 weeks)

Population: The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs).This subset of the FAS included subjects who entered the Maintenance Phase but who never achieved Lacosamide (LCM) monotherapy.

Days on Monotherapy Treatment were defined as the number of days during the Monotherapy Phase when the subject took Lacosamide (LCM) only (ie, the total number of days exposed to LCM during the Monotherapy Phase minus any days where a concomitant or rescue Anti-epileptic Drug (AED) was taken by the subject). The days on Monotherapy Treatment did not need to be consecutive.

Outcome measures

Outcome measures
Measure	Lacosamide 300 mg/Day n=86 Participants Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/Day n=254 Participants Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure.
Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)	71 days Full Range 22.0 • Interval 1.0 to 100.0	71 days Full Range 20.3 • Interval 2.0 to 105.0

SECONDARY outcome

Timeframe: Baseline; Last Visit (approximately 27 weeks)

Population: The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).

For the assessment of the Clinical Global Impression of Change (CGIC), the investigator should provide his/her assessment of the subject's clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status. He was asked the following:Please check the number that best describes the subject's condition over the past 4 weeks compared to Baseline: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse

Outcome measures

Outcome measures
Measure	Lacosamide 300 mg/Day n=99 Participants Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/Day n=284 Participants Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure.
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit Very much improved	21 participants	56 participants
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit Much improved	33 participants	116 participants
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit Minimally improved	18 participants	42 participants
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit No change	8 participants	18 participants
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit Minimally worse	6 participants	16 participants
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit Much worse	8 participants	23 participants
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit Very much worse	1 participants	1 participants
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit Not done	4 participants	12 participants

SECONDARY outcome

Timeframe: Baseline; Last Visit (approximately 27 weeks)

Population: The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).

For the assessment of the Patient's Global Impression of Change, the subject should provide his/her assessment of his/her own clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.The subject was asked to answer the following: Over the past 4 weeks, how have you felt compared to before you entered this clinical trial? (Please check the number that best describes your condition.) 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse

Outcome measures

Outcome measures
Measure	Lacosamide 300 mg/Day n=99 Participants Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/Day n=284 Participants Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure.
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit Very much improved	24 participants	81 participants
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit Much improved	33 participants	93 participants
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit Minimally improved	15 participants	37 participants
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit No change	10 participants	15 participants
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit Minimally worse	3 participants	19 participants
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit Much worse	7 participants	22 participants
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit Very much worse	3 participants	3 participants
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit Not done	4 participants	14 participants

Adverse Events

Lacosamide 300 mg/Day

Serious events: 4 serious events

Other events: 74 other events

Deaths: 0 deaths

Lacosamide 400 mg/Day

Serious events: 21 serious events

Other events: 215 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

UCB Clinical Trial Call Center

UCB

Phone: +1 877 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Lacosamide 300 mg/Day n=106 participants at risk Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/Day n=319 participants at risk Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Gastrointestinal disorders Food poisoning	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Gastrointestinal disorders Glossitis	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
General disorders Sudden unexplained death in epilepsy	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.63% 2/319 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Immune system disorders Hypersensitivity	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Injury, poisoning and procedural complications Limb injury	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Injury, poisoning and procedural complications Polytraumatism	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Injury, poisoning and procedural complications Subdural haematoma	0.94% 1/106 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.00% 0/319 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Metabolism and nutrition disorders Dehydration	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Nervous system disorders Convulsion	0.94% 1/106 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	1.9% 6/319 • Number of events 6 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Nervous system disorders Epilepsy	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Nervous system disorders Headache	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Nervous system disorders Status epilepticus	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Nervous system disorders Toxic induced encephalopathy	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Psychiatric disorders Abnormal behaviour	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Psychiatric disorders Conversion disorder	0.94% 1/106 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.00% 0/319 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Psychiatric disorders Hallucination, auditory	0.94% 1/106 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.00% 0/319 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Psychiatric disorders Hallucination, visual	0.94% 1/106 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.00% 0/319 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Psychiatric disorders Psychotic disorder	0.94% 1/106 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.00% 0/319 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/106 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	0.31% 1/319 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.

Measure	Lacosamide 300 mg/Day n=106 participants at risk Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/Day n=319 participants at risk Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Eye disorders Vision blurred	5.7% 6/106 • Number of events 6 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	6.0% 19/319 • Number of events 25 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Gastrointestinal disorders Nausea	12.3% 13/106 • Number of events 16 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	14.4% 46/319 • Number of events 57 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Gastrointestinal disorders Diarrhoea	6.6% 7/106 • Number of events 9 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	6.6% 21/319 • Number of events 22 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Gastrointestinal disorders Vomiting	1.9% 2/106 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	7.2% 23/319 • Number of events 27 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
General disorders Fatigue	11.3% 12/106 • Number of events 14 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	10.0% 32/319 • Number of events 37 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Infections and infestations Nasopharyngitis	6.6% 7/106 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	8.8% 28/319 • Number of events 30 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Infections and infestations Upper respiratory tract infection	4.7% 5/106 • Number of events 6 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	5.0% 16/319 • Number of events 19 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Musculoskeletal and connective tissue disorders Back pain	8.5% 9/106 • Number of events 9 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	3.4% 11/319 • Number of events 13 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Nervous system disorders Dizziness	17.9% 19/106 • Number of events 26 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	27.0% 86/319 • Number of events 121 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Nervous system disorders Headache	19.8% 21/106 • Number of events 32 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	14.1% 45/319 • Number of events 58 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Nervous system disorders Convulsion	16.0% 17/106 • Number of events 22 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	9.1% 29/319 • Number of events 36 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Nervous system disorders Somnolence	14.2% 15/106 • Number of events 19 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	9.1% 29/319 • Number of events 35 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Nervous system disorders Tremor	7.5% 8/106 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	7.2% 23/319 • Number of events 23 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Nervous system disorders Cognitive disorder	6.6% 7/106 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	1.9% 6/319 • Number of events 6 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Psychiatric disorders Insomnia	7.5% 8/106 • Number of events 10 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	5.3% 17/319 • Number of events 17 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Psychiatric disorders Anxiety	6.6% 7/106 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	3.4% 11/319 • Number of events 13 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Skin and subcutaneous tissue disorders Rash	3.8% 4/106 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.	5.0% 16/319 • Number of events 20 • Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented. Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.