Trial Outcomes & Findings for Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure (NCT NCT01235403)

Results Overview

Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

During the study ( up to 24 - 28 weeks)

Results posted on

2018-05-21

Participant Flow

This is a 24-week study, which enrolled 100 patients at 44 sites in France.

The study comprises a 12-week Titration Phase and a 12-week Maintenance Phase; both phases together are regarded as the 24-week Treatment Period. Participant Flow and Baseline Characteristics refer to the Safety Set (SS). The SS includes all subjects that received at least one dose of study medication.

Participant milestones

Participant milestones
Measure	Lacosamide Flexible dosing between 200 mg/day and 400 mg/day Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks
Overall Study STARTED	100
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Lacosamide Flexible dosing between 200 mg/day and 400 mg/day Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks
Overall Study Adverse Event	14
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	4
Overall Study Lack of Efficacy	2
Overall Study Other reasons for premature termination	4

Baseline Characteristics

Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lacosamide n=100 Participants Flexible dosing between 200mg/day and 400mg/day Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	88 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	44.5 years STANDARD_DEVIATION 16.22 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Region of Enrollment France	100 participants n=5 Participants

PRIMARY outcome

Timeframe: During the study ( up to 24 - 28 weeks)

Population: Safety Set

Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.

Outcome measures

Outcome measures
Measure	Lacosamide n=100 Participants Flexible dosing between 200 mg/day and 400 mg/day Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study	64 subjects

PRIMARY outcome

Timeframe: During the study (up to 24 - 28 weeks)

Population: Safety Set

Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.

Outcome measures

Outcome measures
Measure	Lacosamide n=100 Participants Flexible dosing between 200 mg/day and 400 mg/day Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks
Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study	14 subjects

SECONDARY outcome

Timeframe: End of Treatment Period (24-week)

Population: Safety Set

The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100. The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase.

Outcome measures

Outcome measures
Measure	Lacosamide n=100 Participants Flexible dosing between 200 mg/day and 400 mg/day Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks
Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period	73 percentage of subjects

Adverse Events

Lacosamide

Serious events: 3 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lacosamide n=100 participants at risk Flexible dosing between 200mg/day and 400mg/day Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks
Eye disorders Diplopia	1.0% 1/100 • Number of events 1 • During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Gastrointestinal disorders Nausea	1.0% 1/100 • Number of events 1 • During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Nervous system disorders Coma	1.0% 1/100 • Number of events 1 • During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Nervous system disorders Dizziness	1.0% 1/100 • Number of events 1 • During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
General disorders Gait disturbance	1.0% 1/100 • Number of events 1 • During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Nervous system disorders Partial seizures with secondary generalisation	1.0% 1/100 • Number of events 1 • During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Nervous system disorders Status epilepticus	1.0% 1/100 • Number of events 1 • During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.

Other adverse events

Other adverse events
Measure	Lacosamide n=100 participants at risk Flexible dosing between 200mg/day and 400mg/day Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks
Nervous system disorders Dizziness	42.0% 42/100 • Number of events 46 • During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Nervous system disorders Headache	8.0% 8/100 • Number of events 9 • During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
General disorders Asthenia	5.0% 5/100 • Number of events 5 • During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.

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