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Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures

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ClinicalTrials.gov Identifier: NCT01921205
Recruitment Status : Completed
First Posted : August 13, 2013
Results First Posted : March 19, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Drug: Lacosamide
Other: Placebo
Enrollment 404
Recruitment Details The study started to enroll patients in August 2013 and concluded in January 2017.
Pre-assignment Details The Participant Flow refers to the Safety Set which included all randomized subjects who took at least 1 dose of study medication.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 172 171
Completed 151 151
Not Completed 21 20
Reason Not Completed
Adverse Event             12             7
Lack of Efficacy             1             0
Protocol Violation             1             3
Lost to Follow-up             1             1
Withdrawal by Subject             6             5
Use Of Prohibited Medication             0             1
The Excessive Use Of Rescue Medication             0             1
Non Compliance Of The Parent             0             1
Non Compliance Of Child             0             1
Arm/Group Title Placebo Lacosamide Total Title
Hide Arm/Group Description 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. 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. [Not Specified]
Overall Number of Baseline Participants 172 171 343
Hide Baseline Analysis Population Description
The Baseline Characteristics refers to the Safety Set which included all randomized subjects who took at least 1 dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 171 participants 343 participants
<=18 years
172
 100.0%
171
 100.0%
343
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 172 participants 171 participants 343 participants
10.9  (3.5) 10.5  (3.6) 10.7  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 171 participants 343 participants
Female
73
  42.4%
80
  46.8%
153
  44.6%
Male
99
  57.6%
91
  53.2%
190
  55.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 171 participants 343 participants
American Indian or Alaska Native
1
   0.6%
0
   0.0%
1
   0.3%
Asian
35
  20.3%
25
  14.6%
60
  17.5%
Black or African American
1
   0.6%
2
   1.2%
3
   0.9%
White
129
  75.0%
138
  80.7%
267
  77.8%
Other/Mixed
6
   3.5%
6
   3.5%
12
   3.5%
1.Primary Outcome
Title Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period
Hide Description The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Time Frame Baseline to Week 16 (or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) Lacosamide (FAS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 168 170
Median (Full Range)
Unit of Measure: Seizures per 28 days
-1.55
(-318.7 to 690.0)
-3.05
(-302.9 to 210.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Lacosamide (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0003
Comments [Not Specified]
Method ANCOVA
Comments Seizure frequency (log transformed) is analyzed using analysis of covariance with terms for treatment, pooled center and Baseline seizure frequency.
Method of Estimation Estimation Parameter Percent reduction over Placebo
Estimated Value 31.72
Confidence Interval (2-Sided) 95%
16.342 to 44.277
Estimation Comments Percent reduction over placebo is estimated as 100 x (1-exp[LSMLacosamide-LSMPlacebo]). Where LSM is Least Square Mean.
2.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline to Week 16 (or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) Lacosamide (FAS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 168 170
Measure Type: Number
Unit of Measure: percentage of participants
33.3 52.9
3.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline to Week 16 (or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) Lacosamide (FAS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 170 170
Measure Type: Number
Unit of Measure: percentage of participants
>=25% - <50% 14.7 11.8
>=50% - <=75% 17.1 21.8
>75% 15.9 31.2
4.Secondary Outcome
Title Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
Hide Description The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Time Frame Baseline to Week 16 (or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) Lacosamide (FAS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 169 170
Median (Full Range)
Unit of Measure: Seizures per 28 days
-1.22
(-250.6 to 477.0)
-2.46
(-219.2 to 210.4)
5.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline to Week 16 (or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) Lacosamide (FAS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 170 170
Measure Type: Number
Unit of Measure: percentage of participants
>=25% - <50% 15.3 16.5
>=50% - <=75% 20.6 20.6
>75% 8.8 23.5
6.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline to Week 16 (or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) Lacosamide (FAS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 169 170
Measure Type: Number
Unit of Measure: percentage of participants
32.0 20.6
7.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline to Week 16 (or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) Lacosamide (FAS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 169 170
Measure Type: Number
Unit of Measure: percentage of participants
23.1 18.8
8.Secondary Outcome
Title Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures
Hide Description The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Time Frame Baseline to Week 16 (or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) Lacosamide (FAS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 68 77
Median (Full Range)
Unit of Measure: Seizures per 28 days
-1.14
(-250.6 to 477.0)
-1.25
(-217.4 to 100.2)
9.Secondary Outcome
Title Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures
Hide Description The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Time Frame Baseline to Week 16 (or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) Lacosamide (FAS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 99 109
Median (Full Range)
Unit of Measure: Seizures per 28 days
-0.98
(-78.0 to 239.7)
-2.06
(-131.8 to 210.4)
10.Secondary Outcome
Title Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures
Hide Description The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Time Frame Baseline to Week 16 (or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) Lacosamide (FAS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 69 63
Median (Full Range)
Unit of Measure: Seizures per 28 days
-1.0
(-204.7 to 39.8)
-2.81
(-99.3 to 72.7)
11.Secondary Outcome
Title Proportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period
Hide Description 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.
Time Frame Week 7 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) Lacosamide (FAS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 154 152
Mean (Standard Deviation)
Unit of Measure: days
0.65  (0.35) 0.71  (0.32)
12.Secondary Outcome
Title Proportion of Subjects Who Achieved “Seizure Free” Status (Yes/no) for Subjects Who Completed the Maintenance Period
Hide Description 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.
Time Frame Week 7 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (FAS) Lacosamide (FAS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 154 152
Measure Type: Number
Unit of Measure: percentage of participants
9.7 15.1
Time Frame Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Placebo Lacosamide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/172 (0.00%)      0/171 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Lacosamide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/172 (7.56%)      11/171 (6.43%)    
Cardiac disorders     
Bradycardia * 1  0/172 (0.00%)  0 1/171 (0.58%)  1
Gastrointestinal disorders     
Abdominal pain * 1  2/172 (1.16%)  2 0/171 (0.00%)  0
Vomiting * 1  1/172 (0.58%)  2 1/171 (0.58%)  1
Constipation * 1  1/172 (0.58%)  1 0/171 (0.00%)  0
Gastrointestinal inflammation * 1  0/172 (0.00%)  0 1/171 (0.58%)  1
Hepatobiliary disorders     
Hepatitis * 1  1/172 (0.58%)  1 0/171 (0.00%)  0
Infections and infestations     
Pneumonia * 1  2/172 (1.16%)  2 0/171 (0.00%)  0
Urinary tract infection * 1  1/172 (0.58%)  1 1/171 (0.58%)  1
Bronchitis * 1  0/172 (0.00%)  0 1/171 (0.58%)  1
Bronchopneumonia * 1  0/172 (0.00%)  0 1/171 (0.58%)  1
Dengue fever * 1  0/172 (0.00%)  0 1/171 (0.58%)  1
Gastroenteritis * 1  1/172 (0.58%)  1 0/171 (0.00%)  0
Respiratory tract infection * 1  1/172 (0.58%)  1 0/171 (0.00%)  0
Tonsillitis * 1  1/172 (0.58%)  1 0/171 (0.00%)  0
Injury, poisoning and procedural complications     
Postoperative respiratory distress * 1  1/172 (0.58%)  1 0/171 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/172 (0.58%)  1 1/171 (0.58%)  2
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/172 (0.58%)  1 0/171 (0.00%)  0
Nervous system disorders     
Convulsion * 1  4/172 (2.33%)  5 2/171 (1.17%)  2
Dystonia * 1  1/172 (0.58%)  1 0/171 (0.00%)  0
Partial seizures * 1  0/172 (0.00%)  0 1/171 (0.58%)  4
Syncope * 1  0/172 (0.00%)  0 1/171 (0.58%)  2
Psychiatric disorders     
Emotional disorder of childhood * 1  1/172 (0.58%)  1 0/171 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash maculo-papular * 1  1/172 (0.58%)  1 0/171 (0.00%)  0
1
Term from vocabulary, MedDRA16.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Lacosamide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/172 (35.47%)      85/171 (49.71%)    
Gastrointestinal disorders     
Vomiting * 1  11/172 (6.40%)  15 17/171 (9.94%)  22
Diarrhoea * 1  9/172 (5.23%)  13 8/171 (4.68%)  15
General disorders     
Pyrexia * 1  10/172 (5.81%)  11 17/171 (9.94%)  21
Infections and infestations     
Nasopharyngitis * 1  10/172 (5.81%)  10 20/171 (11.70%)  29
Upper respiratory tract infection * 1  10/172 (5.81%)  14 10/171 (5.85%)  13
Pharyngitis * 1  5/172 (2.91%)  5 10/171 (5.85%)  13
Nervous system disorders     
Somnolence * 1  11/172 (6.40%)  14 28/171 (16.37%)  42
Dizziness * 1  13/172 (7.56%)  14 18/171 (10.53%)  26
Headache * 1  15/172 (8.72%)  25 14/171 (8.19%)  19
1
Term from vocabulary, MedDRA16.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01921205     History of Changes
Other Study ID Numbers: SP0969
2012-004996-38 ( EudraCT Number )
First Submitted: August 8, 2013
First Posted: August 13, 2013
Results First Submitted: January 23, 2018
Results First Posted: March 19, 2018
Last Update Posted: July 18, 2018