Trial Outcomes & Findings for Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures (NCT NCT01921205)
NCT ID: NCT01921205
Last Updated: 2018-07-18
Results Overview
The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
404 participants
Primary outcome timeframe
Baseline to Week 16 (or last value on treatment)
Results posted on
2018-07-18
Participant Flow
The study started to enroll patients in August 2013 and concluded in January 2017.
The Participant Flow refers to the Safety Set which included all randomized subjects who took at least 1 dose of study medication.
Participant milestones
| Measure |
Placebo
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Overall Study
STARTED
|
172
|
171
|
|
Overall Study
COMPLETED
|
151
|
151
|
|
Overall Study
NOT COMPLETED
|
21
|
20
|
Reasons for withdrawal
| Measure |
Placebo
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
7
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Use Of Prohibited Medication
|
0
|
1
|
|
Overall Study
The Excessive Use Of Rescue Medication
|
0
|
1
|
|
Overall Study
Non Compliance Of The Parent
|
0
|
1
|
|
Overall Study
Non Compliance Of Child
|
0
|
1
|
Baseline Characteristics
Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
Baseline characteristics by cohort
| Measure |
Total Title
n=343 Participants
|
Placebo
n=172 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide
n=171 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
343 Participants
n=5 Participants
|
172 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
10.7 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
10.9 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
10.5 years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
153 Participants
n=5 Participants
|
73 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
190 Participants
n=5 Participants
|
99 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
60 Participants
n=5 Participants
|
35 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
267 Participants
n=5 Participants
|
129 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
12 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16 (or last value on treatment)Population: The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with available data were included in this analysis.
The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Outcome measures
| Measure |
Placebo (FAS)
n=168 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide (FAS)
n=170 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period
|
-1.55 Seizures per 28 days
Interval -318.7 to 690.0
|
-3.05 Seizures per 28 days
Interval -302.9 to 210.4
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (or last value on treatment)Population: The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with response data have been included in this analysis.
Proportion of responders is presented as percentage of participants. A responder is a subject experiencing a 50 % or greater reduction in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period.
Outcome measures
| Measure |
Placebo (FAS)
n=168 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide (FAS)
n=170 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Proportion of Responders Where a Responder is Defined as a Participant With >= 50% Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
|
33.3 percentage of participants
|
52.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (or last value on treatment)Population: The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data.
Proportion of subjects is presented as percentage of participants. A \>=25%-\<50% response in the Maintenance Period is defined as \>=25% to \<50% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A \>=50%-\<=75% response in the Maintenance Period is defined as \>=50% to \<=75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A 75% response in the Maintenance Period is defined as \>75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period.
Outcome measures
| Measure |
Placebo (FAS)
n=170 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide (FAS)
n=170 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period
>=25% - <50%
|
14.7 percentage of participants
|
11.8 percentage of participants
|
|
Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period
>=50% - <=75%
|
17.1 percentage of participants
|
21.8 percentage of participants
|
|
Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period
>75%
|
15.9 percentage of participants
|
31.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (or last value on treatment)Population: The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with available data were included in this analysis.
The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Outcome measures
| Measure |
Placebo (FAS)
n=169 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide (FAS)
n=170 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
|
-1.22 Seizures per 28 days
Interval -250.6 to 477.0
|
-2.46 Seizures per 28 days
Interval -219.2 to 210.4
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (or last value on treatment)Population: The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data.
Proportion of subjects is presented as percentage of participants. A \>=25%-\<50% response in the Treatment Period is defined as \>=25% to \<50% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A \>=50%-\<=75% response in the Treatment Period is defined as \>=50% to \<=75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A 75% response in the Treatment Period is defined as \>75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period.
Outcome measures
| Measure |
Placebo (FAS)
n=170 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide (FAS)
n=170 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
>=25% - <50%
|
15.3 percentage of participants
|
16.5 percentage of participants
|
|
Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
>=50% - <=75%
|
20.6 percentage of participants
|
20.6 percentage of participants
|
|
Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
>75%
|
8.8 percentage of participants
|
23.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (or last value on treatment)Population: The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with response data have been included in this analysis.
Proportion of subjects is presented as percentage of participants. No change is defined as between \<25% reduction and \<25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise not between \<25% reduction and \<25% increase is defined as a change.
Outcome measures
| Measure |
Placebo (FAS)
n=169 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide (FAS)
n=170 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Proportion of Subjects Experiencing no Change in Partial Onset Seizure Frequency (Between <25 % Reduction and <25 % Increase) Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
|
32.0 percentage of participants
|
20.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (or last value on treatment)Population: The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with response data have been included in this analysis.
Proportion of subjects is presented as percentage of participants. An increase is defined as a \>=25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise \<25% increase is defined as no increase.
Outcome measures
| Measure |
Placebo (FAS)
n=169 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide (FAS)
n=170 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Proportion of Subjects Experiencing an Increase in Partial Onset Seizure Frequency Per 28 Days of >=25 % From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
|
23.1 percentage of participants
|
18.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (or last value on treatment)Population: The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with Simple Partial Seizures were included in this analysis.
The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Outcome measures
| Measure |
Placebo (FAS)
n=68 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide (FAS)
n=77 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures
|
-1.14 Seizures per 28 days
Interval -250.6 to 477.0
|
-1.25 Seizures per 28 days
Interval -217.4 to 100.2
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (or last value on treatment)Population: The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with Complex Partial Seizures were included in this analysis.
The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Outcome measures
| Measure |
Placebo (FAS)
n=99 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide (FAS)
n=109 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures
|
-0.98 Seizures per 28 days
Interval -78.0 to 239.7
|
-2.06 Seizures per 28 days
Interval -131.8 to 210.4
|
SECONDARY outcome
Timeframe: Baseline to Week 16 (or last value on treatment)Population: The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with Secondary Generalized Seizures were included in this analysis.
The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Outcome measures
| Measure |
Placebo (FAS)
n=69 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide (FAS)
n=63 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures
|
-1.0 Seizures per 28 days
Interval -204.7 to 39.8
|
-2.81 Seizures per 28 days
Interval -99.3 to 72.7
|
SECONDARY outcome
Timeframe: Week 7 to Week 16Population: Percentages are based on the number of subjects in the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects who completed the Maintenance Period have been included in this analysis.
The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded.
Outcome measures
| Measure |
Placebo (FAS)
n=154 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide (FAS)
n=152 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Proportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period
|
0.65 days
Standard Deviation 0.35
|
0.71 days
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Week 7 to Week 16Population: Percentages are based on the number of subjects in the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects who completed the Maintenance Period have been included in this analysis.
The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded.
Outcome measures
| Measure |
Placebo (FAS)
n=154 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide (FAS)
n=152 Participants
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Proportion of Subjects Who Achieved "Seizure Free" Status (Yes/no) for Subjects Who Completed the Maintenance Period
|
9.7 percentage of participants
|
15.1 percentage of participants
|
Adverse Events
Placebo
Serious events: 13 serious events
Other events: 61 other events
Deaths: 0 deaths
Lacosamide
Serious events: 11 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=172 participants at risk
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide
n=171 participants at risk
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/172 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.00%
0/171 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Gastrointestinal disorders
Vomiting
|
0.58%
1/172 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Gastrointestinal disorders
Constipation
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.00%
0/171 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/172 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Hepatobiliary disorders
Hepatitis
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.00%
0/171 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/172 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.00%
0/171 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Infections and infestations
Urinary tract infection
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/172 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/172 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/172 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.58%
1/171 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Infections and infestations
Gastroenteritis
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.00%
0/171 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Infections and infestations
Respiratory tract infection
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.00%
0/171 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Infections and infestations
Tonsillitis
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.00%
0/171 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.00%
0/171 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.58%
1/171 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.00%
0/171 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Nervous system disorders
Convulsion
|
2.3%
4/172 • Number of events 5 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
1.2%
2/171 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Nervous system disorders
Dystonia
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.00%
0/171 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/172 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.58%
1/171 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Nervous system disorders
Syncope
|
0.00%
0/172 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.58%
1/171 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Psychiatric disorders
Emotional disorder of childhood
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.00%
0/171 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.58%
1/172 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
0.00%
0/171 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
Other adverse events
| Measure |
Placebo
n=172 participants at risk
This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
|
Lacosamide
n=171 participants at risk
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
6.4%
11/172 • Number of events 15 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
9.9%
17/171 • Number of events 22 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
9/172 • Number of events 13 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
4.7%
8/171 • Number of events 15 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
General disorders
Pyrexia
|
5.8%
10/172 • Number of events 11 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
9.9%
17/171 • Number of events 21 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
10/172 • Number of events 10 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
11.7%
20/171 • Number of events 29 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
10/172 • Number of events 14 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
5.8%
10/171 • Number of events 13 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Infections and infestations
Pharyngitis
|
2.9%
5/172 • Number of events 5 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
5.8%
10/171 • Number of events 13 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Nervous system disorders
Somnolence
|
6.4%
11/172 • Number of events 14 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
16.4%
28/171 • Number of events 42 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Nervous system disorders
Dizziness
|
7.6%
13/172 • Number of events 14 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
10.5%
18/171 • Number of events 26 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
|
Nervous system disorders
Headache
|
8.7%
15/172 • Number of events 25 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
8.2%
14/171 • Number of events 19 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60