Trial Outcomes & Findings for A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures (NCT NCT01710657)

Last Updated: 2017-08-25

Results Overview

Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

548 participants

Primary outcome timeframe

8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)

Results posted on

2017-08-25

Participant Flow

A total of 676 subjects with uncontrolled partial-onset seizures (of the 676 subjects, the number of Chinese subjects and Japanese subjects was planned to be 507 and 169, respectively) was planned to be screened and 540 subjects were planned to be enrolled in all regions of Japan and China.

Overall, 692 subjects were screened and 548 subjects were enrolled. The Participant Flow refers to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide. Reasons for discontinuation were only calculated for the SS. 547 subjects were included in the Safety Set.

Participant milestones

Participant milestones
Measure	Placebo Matching Placebo for 16 weeks. Placebo: Matching oral Placebo tablets twice daily for 16 weeks.	Lacosamide 200 mg/Day Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use	Lacosamide 400 mg/Day Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use
Overall Study STARTED	184	183	180
Overall Study Titration Period (4 Weeks)	184	183	180
Overall Study Maintenance Period (12 Weeks)	176	175	168
Overall Study COMPLETED	166	171	148
Overall Study NOT COMPLETED	18	12	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Matching Placebo for 16 weeks. Placebo: Matching oral Placebo tablets twice daily for 16 weeks.	Lacosamide 200 mg/Day Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use	Lacosamide 400 mg/Day Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use
Overall Study Lost to Follow-up	2	0	1
Overall Study Protocol Violation	2	2	0
Overall Study Adverse Event	14	8	28
Overall Study Withdrawal by Subject	0	1	2
Overall Study Lack of Efficacy	0	1	1

Baseline Characteristics

A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=184 Participants Matching Placebo for 16 weeks. Placebo: Matching oral Placebo tablets twice daily for 16 weeks.	Lacosamide 200 mg/Day n=183 Participants Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use	Lacosamide 400 mg/Day n=180 Participants Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use	Total n=547 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=99 Participants	18 Participants n=107 Participants	15 Participants n=206 Participants	53 Participants n=157 Participants
Age, Categorical Between 18 and 65 years	164 Participants n=99 Participants	163 Participants n=107 Participants	164 Participants n=206 Participants	491 Participants n=157 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	2 Participants n=107 Participants	1 Participants n=206 Participants	3 Participants n=157 Participants
Age, Continuous	31.8 years STANDARD_DEVIATION 12.0 • n=99 Participants	33.2 years STANDARD_DEVIATION 12.2 • n=107 Participants	32.3 years STANDARD_DEVIATION 11.9 • n=206 Participants	32.4 years STANDARD_DEVIATION 12.0 • n=157 Participants
Sex: Female, Male Female	82 Participants n=99 Participants	89 Participants n=107 Participants	76 Participants n=206 Participants	247 Participants n=157 Participants
Sex: Female, Male Male	102 Participants n=99 Participants	94 Participants n=107 Participants	104 Participants n=206 Participants	300 Participants n=157 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Asian	184 Participants n=99 Participants	183 Participants n=107 Participants	180 Participants n=206 Participants	547 Participants n=157 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race/Ethnicity, Customized Chinese	136 participants n=99 Participants	136 participants n=107 Participants	133 participants n=206 Participants	405 participants n=157 Participants
Race/Ethnicity, Customized Japanese	48 participants n=99 Participants	47 participants n=107 Participants	47 participants n=206 Participants	142 participants n=157 Participants

PRIMARY outcome

Timeframe: 8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)

Population: The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Matching Placebo for 16 weeks. Placebo: Matching oral Placebo tablets twice daily for 16 weeks.	Lacosamide 200 mg/Day n=182 Participants Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use	Lacosamide 400 mg/Day n=179 Participants Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period	-1.22 Seizures per 28 days Interval -93.0 to 39.8	-3.33 Seizures per 28 days Interval -754.3 to 165.2	-4.50 Seizures per 28 days Interval -97.5 to 28.2

SECONDARY outcome

Timeframe: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)

Population: The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Matching Placebo for 16 weeks. Placebo: Matching oral Placebo tablets twice daily for 16 weeks.	Lacosamide 200 mg/Day n=182 Participants Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use	Lacosamide 400 mg/Day n=179 Participants Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use
The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)	36 participants	70 participants	88 participants

SECONDARY outcome

Timeframe: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)

Population: The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.

Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Matching Placebo for 16 weeks. Placebo: Matching oral Placebo tablets twice daily for 16 weeks.	Lacosamide 200 mg/Day n=182 Participants Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use	Lacosamide 400 mg/Day n=179 Participants Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use
Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period	-10.10 percentage change Interval -97.6 to 233.5	-36.75 percentage change Interval -100.0 to 185.5	-48.78 percentage change Interval -100.0 to 346.4

SECONDARY outcome

Timeframe: 8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)

Population: The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Matching Placebo for 16 weeks. Placebo: Matching oral Placebo tablets twice daily for 16 weeks.	Lacosamide 200 mg/Day n=182 Participants Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use	Lacosamide 400 mg/Day n=179 Participants Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)	-1.10 Seizures per 28 days Interval -102.4 to 102.5	-3.39 Seizures per 28 days Interval -670.0 to 138.9	-4.00 Seizures per 28 days Interval -92.4 to 34.2

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 77 other events

Deaths: 0 deaths

Lacosamide 200 mg/Day

Serious events: 2 serious events

Other events: 87 other events

Deaths: 0 deaths

Lacosamide 400 mg/Day

Serious events: 9 serious events

Other events: 112 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=184 participants at risk Matching Placebo for 16 weeks. Placebo: Matching oral Placebo tablets twice daily for 16 weeks.	Lacosamide 200 mg/Day n=183 participants at risk Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use	Lacosamide 400 mg/Day n=180 participants at risk Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use
Nervous system disorders Somnolence	4.9% 9/184 • Number of events 10 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	9.8% 18/183 • Number of events 26 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	10.6% 19/180 • Number of events 21 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Nervous system disorders Headache	6.0% 11/184 • Number of events 21 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	8.7% 16/183 • Number of events 18 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	10.6% 19/180 • Number of events 32 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Eye disorders Diplopia	2.2% 4/184 • Number of events 5 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	2.2% 4/183 • Number of events 8 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	7.2% 13/180 • Number of events 15 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	2.2% 4/184 • Number of events 4 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	2.7% 5/183 • Number of events 6 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	7.8% 14/180 • Number of events 18 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Gastrointestinal disorders Nausea	4.9% 9/184 • Number of events 10 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	3.8% 7/183 • Number of events 8 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	5.6% 10/180 • Number of events 11 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	13.0% 24/184 • Number of events 41 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	15.3% 28/183 • Number of events 40 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	16.1% 29/180 • Number of events 36 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	12.0% 22/184 • Number of events 31 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	5.5% 10/183 • Number of events 14 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	10.6% 19/180 • Number of events 28 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Investigations White blood cell count decreased	1.1% 2/184 • Number of events 2 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	4.4% 8/183 • Number of events 14 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	5.6% 10/180 • Number of events 12 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Nervous system disorders Dizziness	13.0% 24/184 • Number of events 32 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	18.0% 33/183 • Number of events 57 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	35.0% 63/180 • Number of events 118 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.

Additional Information

UCB Clinical Trial Call Center

UCB

Phone: +1 877 822 9493 (UCB)

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Placebo n=184 participants at risk Matching Placebo for 16 weeks. Placebo: Matching oral Placebo tablets twice daily for 16 weeks.	Lacosamide 200 mg/Day n=183 participants at risk Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use	Lacosamide 400 mg/Day n=180 participants at risk Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use Lacosamide 100 mg: - Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use
Ear and labyrinth disorders Vertigo	0.54% 1/184 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/180 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.56% 1/180 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.56% 1/180 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Infections and infestations Bronchitis	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.56% 1/180 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Infections and infestations Pneumonia	0.54% 1/184 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.56% 1/180 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.56% 1/180 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.56% 1/180 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.56% 1/180 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.56% 1/180 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.55% 1/183 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/180 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.56% 1/180 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Nervous system disorders Grand mal convulsion	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.56% 1/180 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Nervous system disorders Status epilepticus	1.1% 2/184 • Number of events 2 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/180 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Psychiatric disorders Epileptic psychosis	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.56% 1/180 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Psychiatric disorders Suicide attempt	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.55% 1/183 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/180 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
Surgical and medical procedures Abortion induced	0.00% 0/184 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.00% 0/183 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.	0.56% 1/180 • Number of events 1 • Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19). Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.