CompletedNCT02477839Updated Jul 1, 2021Results posted

Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures

A Phase 3 interventional study of Lacosamide and Placebo in Epilepsy With Partial-onset Seizures, sponsored by UCB BIOSCIENCES, Inc.. Completed at 88 sites in 26 countries. Open to participants aged 1 Month to 47 Months. Per ClinicalTrials.gov, last updated 2021-07-01.

Sponsored by UCB BIOSCIENCES, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 255
Allocation: Randomized
Ages: 1 Month to 47 Months
Sex: All

Study summary

The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled partial-onset seizures.

Read the detailed description

The trial consists of a 7-day Baseline Period, a 20-day Titration Period, a 7-day Maintenance Period, and a 12-day Transition Period for subjects who complete the study and choose to enter the extension study. Subjects who will not enter the extension study will continue after the Maintenance Period with a 16-day Taper Period followed by a 30-day Safety Follow-Up Period. The Taper Period and Safety Follow-Up are also applicable for subjects not eligible for continuation and therefore ending the study earlier.

If subjects meet the eligibility criteria, they will be randomized to receive either lacosamide 8 mg/kg/day to 12 mg/kg/day, or placebo during the Maintenance Phase. The dose of lacosamide will be titrated from 4 mg/kg/day at study start to maximum of 12 mg/kg/day at 4-day intervals of 1-2 mg/kg/day.

All subjects who complete the 20-day Titration Period will enter the 7-day Maintenance Period. No dose adjustment is allowed during the Maintenance Phase. The Treatment Phase is defined as the combined Titration and Maintenance Phases.

Conditions studied

Epilepsy With Partial-onset Seizures

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Keywords

Epilepsy
children
partial-onset seizures
lacosamide
LCM
pediatric

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 255 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

UCB BIOSCIENCES, Inc. is the lead sponsor of 28 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Month to 47 Months
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subject is male or female from >=1 month (ie, 4 weeks after full term [37 weeks gestational age]) to \<4 years of age
Subject has a diagnosis of epilepsy with partial-onset seizures. The results of >=1 prior EEG and >=1 magnetic resonance imaging/computerized tomography scan should be consistent with this diagnosis
Subject weighs >=4 kg to \<30 kg at Visit 1
Subject has experienced >=2 partial-onset seizures with or without secondary generalization during each consecutive 7-day period during the 2 weeks prior to Visit 1
Subject has >=2 partial-onset seizures with or without secondary generalization during the End-of-Baseline video-EEG. Electrographic seizures are defined as recognizable ictal patterns on an EEG involving >=2 contiguous electrodes. The seizures are initiated as a unilateral or strongly asymmetric abnormal epileptiform discharge lasting a total of >10 seconds
Subject is on a stable (concurrently or sequentially) dosage regimen of 1 to 3 AEDs. The dosage regimen of concomitant AED therapy must be kept constant for a period of >=2 weeks prior to Visit 1. A stable daily dosage regimen of a concomitant benzodiazepine (BZD) will be considered as a concomitant AED
Vagus nerve stimulation (VNS) is allowed and will not be counted as a concomitant AED. The VNS device must have been implanted for >=6 months prior to Visit 1; device settings must be kept stable for >=2 weeks prior to Visit 1 and kept stable during the Baseline, Treatment, and Transition Periods. Use of the VNS device magnet is allowed
Subject is an acceptable candidate for venipuncture

Exclusion criteria

Exclusion Criteria:

Subject has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to partial-onset seizures is not exclusionary
Subject is on a ketogenic diet that has either changed within the 4 weeks prior to Visit 1 or is expected to change during the study
Subject has creatinine clearance \<30 mL/minute
Subject has a clinically relevant ECG abnormality, in the opinion of the investigator (eg, second or third degree heart block at rest or a corrected QT interval [QTc] >=450 ms)
Subject has a hemodynamically significant congenital heart disease
Subject has an arrhythmic heart condition requiring medical therapy
Subject has a known history of severe anaphylactic reaction secondary to medication intake or serious blood dyscrasias
Subject has nonepileptic events that could be confused with seizures. Subjects may be included if epileptic events can be clearly distinguished and the frequency meets the study inclusion criteria
Subject has a current diagnosis of Lennox-Gastaut syndrome, epilepsia partialis continua, primary generalized epilepsy, Dravet Syndrome, or seizures that are not of partial-onset origin
Subject has a history of generalized convulsive status epilepticus \<=2 months prior to Screening (Visit 1)
Subject has been treated with felbamate and has experienced any serious toxicity issues (defined as liver failure, aplastic anemia) with this treatment. Subjects treated with felbamate for \<12 months are excluded. Subjects treated with felbamate for >=12 months prior to Visit 1 and who have not experienced serious toxicity issues are eligible
Subject has an acute or subacutely progressive central nervous system disease. Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease (malignant brain tumor or Rasmussen Syndrome)
Subject has a known cardiac sodium channelopathy, such as Brugada syndrome

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 255 participants (actual)

Study arms

Experimental
Lacosamide
Lacosamide syrup 8 mg/kg/day to 12 mg/kg/day
Drug: Lacosamide
Placebo comparator
Placebo
Matching placebo syrup
Other: Placebo

Interventions

DrugLacosamide
Active Substance: Lacosamide Pharmaceutical Form: Syrup Concentration: 10 mg/mL Route of Administration: oral
Also known as: Vimpat, UCB Code: SPM 927, Abbreviated name: LCM
OtherPlacebo
Active Substance: Placebo Pharmaceutical Form: Syrup Concentration: N/A Route of Administration: oral
Also known as: PBO

What researchers measure

Primary outcomes

Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
The change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-electroencephalogram (EEG) compared to the End-of-Baseline Period video-EEG. Seizure frequency was analyzed using an analysis of covariance (ANCOVA) with terms for treatment, pooled randomized age stratum, pooled center, and Baseline seizure ADF. Seizure ADF was log transformed using the transformation of ln(X+1), where X is the seizure ADF. Baseline seizure ADF was log transformed. Least squares means were based on log-transformed data of the full ANCOVA model.
Time frame: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Participant Withdrawals Due to Adverse Events (AEs) During the Study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Time frame: From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days)
Percentage of Participants With Adverse Events Reported Spontaneously by the Participant's Parent(s) and/or Legal Representative(s)/Caregiver(s) (in Accordance With Local Regulation) or Observed by the Investigator
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Time frame: From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days)

Secondary outcomes

Absolute Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
The absolute change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG.
Time frame: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Percent Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
The percent change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG.
Time frame: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Percentage of Participants Who Achieved 'Seizure-free' Status From All Seizure Types During the End-of-Maintenance (EOM) Period Video-EEG
A study participant was considered seizure-free from all seizures if the End-of-Maintenance (EOM) Period video-EEG had zero seizures reported from all seizure types (not just partial-onset seizures (POS)).
Time frame: During the End-of-Maintenance Period (Day 24 to Day 27)
Percentage of Participants Who Achieved 'Seizure-free' Status From Partial-onset Seizure Types Only During the End-of-Maintenance (EOM) Period Video-EEG
A study participant was considered seizure free from partial-onset seizures (POS) if the End-of-Maintenance (EOM) Period video-EEG had zero POS reported.
Time frame: During the End-of-Maintenance Period (Day 24 to Day 27)
Percentage of Participants Experiencing a >=25% to <50% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
A ≥25% to \<50% response was defined as ≥25% to \<50% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.
Time frame: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Percentage of Participants Experiencing a 50% to 75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
A ≥50% to ≤75% response was defined as ≥50% to ≤75% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.
Time frame: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Percentage of Participants Experiencing a >75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
A \>75% response was defined as \>75% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.
Time frame: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Percentage of Participants Experiencing no Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures (Between <25% Reduction and <25% Increase) From EOB Period Video-EEG to EOM Period Video-EEG
No change was defined as between \<25% reduction and \<25% increase in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.
Time frame: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Percentage of Participants Experiencing an Increase in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures of >=25% From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
An increase was defined as ≥25% increase in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.
Time frame: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)

Results

Posted Jul 1, 2021

Participant flow

The study started to enroll patients in June 2015 and concluded in May 2020.

Participant flow — Overall Study
Milestone	Placebo	Lacosamide
Started	127	128
Completed transition period	124	117
Completed taper after maintenance	0	1
Completed	124	118
Not completed	3	10
Withdrew: Adverse event	0	1
Withdrew: Protocol violation	0	2
Withdrew: Withdrawal by subject	3	3
Withdrew: Participant had pgs during v6	0	1
Withdrew: Parents decided to stop medication	0	1
Withdrew: Lack of tolerability	0	1
Withdrew: Exclusion criterion	0	1

Outcome measures

PrimaryChange in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG

The change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-electroencephalogram (EEG) compared to the End-of-Baseline Period video-EEG. Seizure frequency was analyzed using an analysis of covariance (ANCOVA) with terms for treatment, pooled randomized age stratum, pooled center, and Baseline seizure ADF. Seizure ADF was log transformed using the transformation of ln(X+1), where X is the seizure ADF. Baseline seizure ADF was log transformed. Least squares means were based on log-transformed data of the full ANCOVA model.

Time frame:: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Reported as:: Least squares mean · percent change

Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
percent change	Placebo (FAS)	Lacosamide (FAS)
Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG	1.44 ± 0.06	1.40 ± 0.06

Statistical analysis

Placebo (FAS) vs Lacosamide (FAS) · ANCOVA · Mean difference (final values): 0.97 · 95% CI 0.83 to 1.14
Placebo (FAS) vs Lacosamide (FAS) · ANCOVA · p = =0.6895 · Percent reduction: 3.19 · 95% CI -13.59 to 17.50

PrimaryParticipant Withdrawals Due to Adverse Events (AEs) During the Study

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.

Time frame:: From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days)
Reported as:: Number · percentage of participants

Participant Withdrawals Due to Adverse Events (AEs) During the Study
percentage of participants	Placebo (SS)	Lacosamide (SS)
Participant Withdrawals Due to Adverse Events (AEs) During the Study	0	1.6

PrimaryPercentage of Participants With Adverse Events Reported Spontaneously by the Participant's Parent(s) and/or Legal Representative(s)/Caregiver(s) (in Accordance With Local Regulation) or Observed by the Investigator

Time frame:: From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days)
Reported as:: Number · percentage of participants

Percentage of Participants With Adverse Events Reported Spontaneously by the Participant's Parent(s) and/or Legal Representative(s)/Caregiver(s) (in Accordance With Local Regulation) or Observed by the Investigator
percentage of participants	Placebo (SS)	Lacosamide (SS)
Percentage of Participants With Adverse Events Reported Spontaneously by the Participant's Parent(s) and/or Legal Representative(s)/Caregiver(s) (in Accordance With Local Regulation) or Observed by the Investigator	59.1	56.3

SecondaryAbsolute Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG

The absolute change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG.

Time frame:: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Reported as:: Mean · seizures per day

Absolute Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
seizures per day	Placebo (FAS)	Lacosamide (FAS)
Absolute Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG	-4.7650 ± 18.0115	-2.9427 ± 7.4938

SecondaryPercent Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG

The percent change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG.

Time frame:: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Reported as:: Mean · percent change

Percent Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
percent change	Placebo (FAS)	Lacosamide (FAS)
Percent Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG	-26.7927 ± 58.5564	-32.3564 ± 65.0255

SecondaryPercentage of Participants Who Achieved 'Seizure-free' Status From All Seizure Types During the End-of-Maintenance (EOM) Period Video-EEG

A study participant was considered seizure-free from all seizures if the End-of-Maintenance (EOM) Period video-EEG had zero seizures reported from all seizure types (not just partial-onset seizures (POS)).

Time frame:: During the End-of-Maintenance Period (Day 24 to Day 27)
Reported as:: Number · percentage of participants

Percentage of Participants Who Achieved 'Seizure-free' Status From All Seizure Types During the End-of-Maintenance (EOM) Period Video-EEG
percentage of participants	Placebo (FAS)	Lacosamide (FAS)
Percentage of Participants Who Achieved 'Seizure-free' Status From All Seizure Types During the End-of-Maintenance (EOM) Period Video-EEG	15.8	17.1

SecondaryPercentage of Participants Who Achieved 'Seizure-free' Status From Partial-onset Seizure Types Only During the End-of-Maintenance (EOM) Period Video-EEG

A study participant was considered seizure free from partial-onset seizures (POS) if the End-of-Maintenance (EOM) Period video-EEG had zero POS reported.

Time frame:: During the End-of-Maintenance Period (Day 24 to Day 27)
Reported as:: Number · percentage of participants

Percentage of Participants Who Achieved 'Seizure-free' Status From Partial-onset Seizure Types Only During the End-of-Maintenance (EOM) Period Video-EEG
percentage of participants	Placebo (FAS)	Lacosamide (FAS)
Percentage of Participants Who Achieved 'Seizure-free' Status From Partial-onset Seizure Types Only During the End-of-Maintenance (EOM) Period Video-EEG	16.7	18.8

SecondaryPercentage of Participants Experiencing a >=25% to <50% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG

A ≥25% to \<50% response was defined as ≥25% to \<50% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.

Time frame:: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Reported as:: Number · percentage of participants

Percentage of Participants Experiencing a >=25% to <50% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
percentage of participants	Placebo (FAS)	Lacosamide (FAS)
Percentage of Participants Experiencing a >=25% to <50% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG	18.3	18.1

SecondaryPercentage of Participants Experiencing a 50% to 75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG

A ≥50% to ≤75% response was defined as ≥50% to ≤75% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.

Time frame:: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Reported as:: Number · percentage of participants

Percentage of Participants Experiencing a 50% to 75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
percentage of participants	Placebo (FAS)	Lacosamide (FAS)
Percentage of Participants Experiencing a 50% to 75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG	17.5	10.3

SecondaryPercentage of Participants Experiencing a >75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG

A \>75% response was defined as \>75% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.

Time frame:: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Reported as:: Number · percentage of participants

Percentage of Participants Experiencing a >75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
percentage of participants	Placebo (FAS)	Lacosamide (FAS)
Percentage of Participants Experiencing a >75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG	20.0	31.0

SecondaryPercentage of Participants Experiencing no Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures (Between <25% Reduction and <25% Increase) From EOB Period Video-EEG to EOM Period Video-EEG

No change was defined as between \<25% reduction and \<25% increase in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.

Time frame:: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Reported as:: Number · percentage of participants

Percentage of Participants Experiencing no Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures (Between <25% Reduction and <25% Increase) From EOB Period Video-EEG to EOM Period Video-EEG
percentage of participants	Placebo (FAS)	Lacosamide (FAS)
Percentage of Participants Experiencing no Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures (Between <25% Reduction and <25% Increase) From EOB Period Video-EEG to EOM Period Video-EEG	28.3	27.6

SecondaryPercentage of Participants Experiencing an Increase in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures of >=25% From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG

An increase was defined as ≥25% increase in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG.

Time frame:: End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Reported as:: Number · percentage of participants

Percentage of Participants Experiencing an Increase in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures of >=25% From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
percentage of participants	Placebo (FAS)	Lacosamide (FAS)
Percentage of Participants Experiencing an Increase in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures of >=25% From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG	15.0	12.9

Adverse events

Collected over Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo (SS)	0/127 (0%)	6/127 (4.7%)	30/127 (23.6%)
Lacosamide (SS)	0/128 (0%)	6/128 (4.7%)	31/128 (24.2%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	Placebo (SS)	Lacosamide (SS)
VomitingGastrointestinal disorders	0/127	2/128
ConvulsionNervous system disorders	0/127	2/128
PyrexiaGeneral disorders	1/127	0/128
Oral herpesInfections and infestations	1/127	0/128
Upper respiratory tract infectionInfections and infestations	1/127	0/128
Urinary tract infectionInfections and infestations	1/127	0/128
Thermal burnInjury, poisoning and procedural complications	1/127	0/128
DehydrationMetabolism and nutrition disorders	1/127	0/128
Pneumonia aspirationRespiratory, thoracic and mediastinal disorders	1/127	0/128
Respiratory failureRespiratory, thoracic and mediastinal disorders	1/127	0/128

Most frequent other events

Most frequent other events
Event	Placebo (SS)	Lacosamide (SS)
SomnolenceNervous system disorders	5/127	18/128
PyrexiaGeneral disorders	15/127	7/128
Upper respiratory tract infectionInfections and infestations	13/127	6/128
IrritabilityGeneral disorders	6/127	7/128

Baseline characteristics

Baseline Characteristics refer to the Safety Set (SS) which consisted of all randomized study participants who took at least 1 dose of study medication.

Age, Categorical
Age, Categorical(Participants)	Placebo	Lacosamide	Total Title
<=18 years	127	128	255
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Age, Continuous
Age, Continuous(months)	Placebo	Lacosamide	Total Title
Mean	26.1 ± 13.4	25.2 ± 13.6	25.6 ± 13.5

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Lacosamide	Total Title
Female	52	57	109
Male	75	71	146

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Placebo	Lacosamide	Total Title
American Indian/Alaskan Native	5	13	18
Asian	15	14	29
Black	0	2	2
White	101	94	195
Other/Mixed	6	5	11

Study locations

88 sites

Sp0967 638
Birmingham, Alabama 35233, United States
Sp0967 117
Tampa, Florida 33609, United States
Sp0967 115
Henderson, Nevada 89052, United States
Sp0967 120
Lebanon, New Hampshire 03756, United States
Sp0967 129
Dallas, Texas 75235, United States
Sp0967 630
San Antonio, Texas 78207, United States
Sp0967 643
San Antonio, Texas 78249, United States
Sp0967 142
Córdoba, Argentina
Sp0967 158
Passo Fundo, Brazil
Sp0967 152
Porto Alegre, Brazil
Sp0967 150
São Paulo, Brazil
Sp0967 154
São Paulo, Brazil
Sp0967 310
Plovdiv, Bulgaria
Sp0967 530
Beijing, China
Sp0967 535
Changchun, China
Sp0967 532
Chongqing, China
Sp0967 536
Nanchang, China
Sp0967 531
Shanghai, China
Sp0967 537
Shenzhen, China
Sp0967 613
Osijek, Croatia
Sp0967 610
Rijeka, Croatia
Sp0967 612
Zagreb, Croatia
Sp0967 320
Ostrava-Poruba, Czechia
Sp0967 349
Marseille, France
Sp0967 346
Rennes, France
Sp0967 344
Strasbourg, France
Sp0967 620
Tbilisi, Georgia
Sp0967 621
Tbilisi, Georgia
Sp0967 622
Tbilisi, Georgia
Sp0967 623
Tbilisi, Georgia
Sp0967 542
Athens, Greece
Sp0967 361
Budapest, Hungary
Sp0967 362
Budapest, Hungary
Sp0967 363
Budapest, Hungary
Sp0967 364
Budapest, Hungary
Sp0967 368
Budapest, Hungary
Sp0967 374
Petah tikva, Israel
Sp0967 397
Genova, Italy
Sp0967 398
Messina, Italy
Sp0967 381
Milano, Italy
Sp0967 700
Napoli, Italy
Sp0967 383
Roma, Italy
Sp0967 395
Roma, Italy
Sp0967 212
Seoul, Korea, Republic of
Sp0967 215
Seoul, Korea, Republic of
Sp0967 694
Aguascalientes, Mexico
Sp0967 561
Chihuahua, Mexico
Sp0967 569
Culiacán, Mexico
Sp0967 693
Culiacán, Mexico
Sp0967 563
Guadalajara, Mexico
Sp0967 564
Mexico, Mexico
Sp0967 568
Monterrey, Mexico
Sp0967 692
Monterrey, Mexico
Sp0967 650
Chisinau, Moldova, Republic of
Sp0967 720
Cebu, Philippines
Sp0967 724
Cebu, Philippines
Sp0967 721
Manila, Philippines
Sp0967 723
Manila, Philippines
Sp0967 727
Quezon City, Philippines
Sp0967 422
Kraków, Poland
Sp0967 750
Lisbon, Portugal
Sp0967 581
Bucuresti, Romania
Sp0967 582
Iaşi, Romania
Sp0967 573
Sibiu, Romania
Sp0967 577
Timişoara, Romania
Sp0967 454
Kemerovo, Russian Federation
Sp0967 456
Nizhny Novgorod, Russian Federation
Sp0967 452
Novosibirsk, Russian Federation
Sp0967 453
Omsk, Russian Federation
Sp0967 455
Perm, Russian Federation
Sp0967 730
Smolensk, Russian Federation
Sp0967 458
Tomsk, Russian Federation
Sp0967 459
Ulyanovsk, Russian Federation
Sp0967 450
Yekaterinburg, Russian Federation
Sp0967 461
Belgrade, Serbia
Sp0967 464
Belgrade, Serbia
Sp0967 463
Novi Sad, Serbia
Sp0967 474
Bratislava, Slovakia
Sp0967 224
Taipei, Taiwan
Sp0967 237
Bangkok, Thailand
Sp0967 235
Pathum Wan, Thailand
Sp0967 602
Dnipropetrovs'k, Ukraine
Sp0967 609
Dnipro, Ukraine
Sp0967 681
Ivano-Frankivs'k, Ukraine
Sp0967 600
Kiev, Ukraine
Sp0967 606
Kiev, Ukraine
Sp0967 682
Uzhgorod, Ukraine
Sp0967 603
Vinnytsia, Ukraine

References and documents

Study documents

Study protocol · Apr 5, 2018
Statistical analysis plan · May 7, 2020

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02477839
Lead sponsor: UCB BIOSCIENCES, Inc.
Responsible party: Sponsor
First posted: Jun 23, 2015
Start date: Jun 5, 2015
Primary completion: May 28, 2020
Completion: May 28, 2020
Results posted: Jul 1, 2021
Last update: Jul 1, 2021

Study contacts

UCB Cares

study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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