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CompletedNCT01921205Updated Jul 18, 2018Results posted

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

A Phase 3 interventional study of Lacosamide and Placebo in Epilepsy, sponsored by UCB Pharma. Completed at 118 sites in 28 countries. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2018-07-18.

Sponsored by UCB Pharma (part of UCB S.A.) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
404
Allocation
Randomized
Ages
4 Years to 16 Years
Sex
All
01

Study summary

Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to \<17 years of age who currently have uncontrolled partial onset seizures.

Read the detailed description

The primary objective of this study is to evaluate the efficacy of LCM administered concomitantly with 1 to ≤3 Anti-Epileptic Drugs (AEDs) in subjects with epilepsy ≥4 years to \<17 years of age who currently have uncontrolled partial onset seizures.

The secondary objective is to evaluate the safety and tolerability of LCM in subjects ≥4 years to \<17 years of age.

An additional objective is to evaluate the pharmacokinetics (PK) of LCM in subjects ≥4 years to \<17 years of age.

02

Conditions studied

  • Epilepsy

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Keywords

  • Lacosamide
  • Vimpat
  • UCB
  • Epilepsy
  • Partial Onset Seizures
  • Pediatric
03

In context

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.

This study's enrollment of 404 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

UCB Pharma is the lead sponsor of 242 studies on the registry; none are open to participants now.

Browse UCB Pharma studies →All UCB S.A. studies →

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

04

Who can participate

Ages eligible
4 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written form is signed and dated by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors
  • Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator
  • Subject is male or female from ≥4 years to \<17 years of age
  • Subject has a diagnosis of Epilepsy with partial-onset seizures. The results of ≥1 prior electroencephalogram (EEG) AND 1 prior magnetic resonance imaging/computerized tomography scan should be consistent with the above diagnosis
  • Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment (in the opinion of the investigator) with ≥2 Anti-Epileptic Drugs (AEDs) (concurrently or sequentially)
  • Subject must have been observed to have on average ≥2 partial onset seizures per 28 days with seizure free phase no longer than 21 days in the 8 week period prior to entry into the Baseline Period. During this study, subjects must have reported ≥2 partial onset seizures during the 8 week prospective Baseline Period to be eligible for randomization at Visit 2. (Note: In the case of simple partial onset seizures, only those seizures with motor signs will be counted towards meeting the inclusion criterion.)
  • Subject is on a stable dosage regimen of 1 to ≤3 AEDs. The daily dosage regimen of concomitant AED therapy must be kept constant for a period of ≥4 weeks prior to the Baseline Period
  • Vagal nerve stimulation (VNS) is allowed and will not be counted as a concomitant AED. The VNS device must be implanted for ≥6 months before Visit 1, and the device settings must be stable for ≥4 weeks before Visit 1 and be kept stable during the Baseline Period. Use of the VNS device magnet is allowed

Exclusion criteria

Exclusion Criteria:

  • Subject has previously participated in this study or subject has been assigned to Lacosamide (LCM) in a previous LCM study
  • Subject has participated in another study of an medicinal product (IMP) or a medical device within ≤2 months of Visit 1 or is currently participating in another study of an IMP or a medical device
  • Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
  • Subject ≥6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C SSRS) at Screening
  • Subject has a known to any component of the IMP or has ever received LCM
  • Female subject who is pregnant or nursing, and/or a female subject of who is not surgically sterile or does not practice 1 highly effective method of (according to International Conference on Harmonisation [ICH] guidance defined as those that result in a failure rate of less than 1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study. Female subject of childbearing potential taking enzyme inducing antiepileptic drugs (EI AEDs: carbamazepine, phenytoin, barbiturates, primidone, topiramate, oxcarbazepine) who is not surgically sterile or does not practice 1 highly effective method of contraception according to the WHO recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices, combined injectables, and progestogen implants) with administration of EI AEDs OR does not practice 2 combined methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study
  • Subject has a medical condition that could be expected in the opinion of the investigator to interfere with drug absorption, distribution, metabolism, or excretion
  • Subject has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to other unprovoked seizures is not exclusionary
  • Subject is on a ketogenic or other specialized diet. If the subject was on a specialized diet in the past, they must be off the diet for ≥2 months prior to the Baseline Period
  • Subject has an (ALT), aspartate aminotransferase (AST), or total level ≥2 times the (ULN), or less than 30 mL/min
  • Subject has a abnormality, in the opinion of the investigator (eg, second or third degree heart block at rest or a interval [QTc] greater than 450 ms)
  • Subject has hemodynamically significant congenital heart disease
  • Subject has an arrhythmic heart condition requiring medical therapy
  • Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias
  • Subject has nonepileptic events that could be confused with seizures
  • Subject has a current diagnosis of Lennox-Gastaut syndrome, primary generalized epilepsy, mixed seizure disorder (partial and primarily generalized seizures), or purely nocturnal seizures
  • Subject has a history of convulsive status epilepticus ≤2 months prior to the Baseline Period
  • Subject has been treated with vigabatrin and experienced any vision loss. Subjects who have received vigabatrin in the past must have documentation of an assessment for vision loss prior to study entry or documentation of why visual field testing cannot be performed
  • 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. Note: any subject who has been treated with felbamate for ≥12 months and has not experienced serious toxicity issues is eligible
  • Subject has a medically documented history of alcohol or drug abuse
  • Subject has a known cardiac sodium channelopathy, such as Brugada syndrome
  • Subject has an acute or sub acutely 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)
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

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

Study arms

  • Experimental
    Lacosamide

    Drug: Lacosamide

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • DrugLacosamide

    Subjects \<30 kg (LCM oral solution): 4 mg/kg - 6 mg/kg BID ( 8mg/kg/day - 12 mg/kg/day) Subjects ≥30 kg to \<50 kg (LCM oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day) Subjects ≥50 kg (LCM tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)

    Also known as: Vimpat(R)

  • OtherPlacebo

    Subjects \<30 kg (placebo oral solution): 4 mg/kg - 6 mg/kg BID (8 mg/kg/day - 12 mg/kg/day) Subjects ≥30 kg to \<50 kg (placebo oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day) Subjects ≥50 kg (placebo tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)

06

What researchers measure

Primary outcomes

  1. Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period

    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)

Secondary outcomes

  1. 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

    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)

  2. 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

    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)

  3. Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)

    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)

  4. 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)

    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)

  5. 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)

    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)

  6. 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)

    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)

  7. Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures

    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)

  8. Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures

    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)

  9. Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures

    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)

  10. Proportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period

    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

  11. Proportion of Subjects Who Achieved "Seizure Free" Status (Yes/no) for Subjects Who Completed the Maintenance Period

    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

07

Results

Posted Mar 19, 2018

Participant flow

The study started to enroll patients in August 2013 and concluded in January 2017.

Participant flow — Overall Study
MilestonePlaceboLacosamide
Started172171
Completed151151
Not completed2120
Withdrew: Adverse event127
Withdrew: Lack of efficacy10
Withdrew: Protocol violation13
Withdrew: Lost to follow-up11
Withdrew: Withdrawal by subject65
Withdrew: Use of prohibited medication01
Withdrew: The excessive use of rescue medication01
Withdrew: Non compliance of the parent01
Withdrew: Non compliance of child01

Outcome measures

PrimaryChange in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period

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)
Reported as:
Median · Seizures per 28 days
Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period
Seizures per 28 daysPlacebo (FAS)Lacosamide (FAS)
Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period-1.55 (-318.7 to 690.0)-3.05 (-302.9 to 210.4)
Statistical analysis
  • Placebo (FAS) vs Lacosamide (FAS) · ANCOVA · p = =0.0003 · Percent reduction over placebo: 31.72 · 95% CI 16.342 to 44.277Percent reduction over placebo is estimated as 100 x (1-exp\[LSMLacosamide-LSMPlacebo\]). Where LSM is Least Square Mean.
SecondaryProportion 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

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)
Reported as:
Number · percentage of participants
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
percentage of participantsPlacebo (FAS)Lacosamide (FAS)
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 Period33.352.9
SecondaryProportion 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

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)
Reported as:
Number · 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
percentage of participantsPlacebo (FAS)Lacosamide (FAS)
>=25% - <50%14.711.8
>=50% - <=75%17.121.8
>75%15.931.2
SecondaryChange in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)

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)
Reported as:
Median · Seizures per 28 days
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
Seizures per 28 daysPlacebo (FAS)Lacosamide (FAS)
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)-1.22 (-250.6 to 477.0)-2.46 (-219.2 to 210.4)
SecondaryProportion 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)

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)
Reported as:
Number · 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)
percentage of participantsPlacebo (FAS)Lacosamide (FAS)
>=25% - <50%15.316.5
>=50% - <=75%20.620.6
>75%8.823.5
SecondaryProportion 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)

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)
Reported as:
Number · percentage of participants
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)
percentage of participantsPlacebo (FAS)Lacosamide (FAS)
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)32.020.6
SecondaryProportion 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)

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)
Reported as:
Number · percentage of participants
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)
percentage of participantsPlacebo (FAS)Lacosamide (FAS)
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)23.118.8
SecondaryChange in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures

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)
Reported as:
Median · Seizures per 28 days
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures
Seizures per 28 daysPlacebo (FAS)Lacosamide (FAS)
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 (-250.6 to 477.0)-1.25 (-217.4 to 100.2)
SecondaryChange in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures

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)
Reported as:
Median · Seizures per 28 days
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures
Seizures per 28 daysPlacebo (FAS)Lacosamide (FAS)
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 (-78.0 to 239.7)-2.06 (-131.8 to 210.4)
SecondaryChange in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures

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)
Reported as:
Median · Seizures per 28 days
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures
Seizures per 28 daysPlacebo (FAS)Lacosamide (FAS)
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 (-204.7 to 39.8)-2.81 (-99.3 to 72.7)
SecondaryProportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period

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
Reported as:
Mean · days
Proportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period
daysPlacebo (FAS)Lacosamide (FAS)
Proportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period0.65 ± 0.350.71 ± 0.32
SecondaryProportion of Subjects Who Achieved "Seizure Free" Status (Yes/no) for Subjects Who Completed the Maintenance Period

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
Reported as:
Number · percentage of participants
Proportion of Subjects Who Achieved "Seizure Free" Status (Yes/no) for Subjects Who Completed the Maintenance Period
percentage of participantsPlacebo (FAS)Lacosamide (FAS)
Proportion of Subjects Who Achieved "Seizure Free" Status (Yes/no) for Subjects Who Completed the Maintenance Period9.715.1

Adverse events

Collected over Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/172 (0%)13/172 (7.6%)61/172 (35.5%)
Lacosamide0/171 (0%)11/171 (6.4%)85/171 (49.7%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventPlaceboLacosamide
ConvulsionNervous system disorders4/1722/171
Abdominal painGastrointestinal disorders2/1720/171
PneumoniaInfections and infestations2/1720/171
BradycardiaCardiac disorders0/1721/171
VomitingGastrointestinal disorders1/1721/171
Gastrointestinal inflammationGastrointestinal disorders0/1721/171
Urinary tract infectionInfections and infestations1/1721/171
BronchitisInfections and infestations0/1721/171
BronchopneumoniaInfections and infestations0/1721/171
Dengue feverInfections and infestations0/1721/171
Most frequent other events
Most frequent other events
EventPlaceboLacosamide
SomnolenceNervous system disorders11/17228/171
NasopharyngitisInfections and infestations10/17220/171
DizzinessNervous system disorders13/17218/171
VomitingGastrointestinal disorders11/17217/171
PyrexiaGeneral disorders10/17217/171
HeadacheNervous system disorders15/17214/171
Upper respiratory tract infectionInfections and infestations10/17210/171
PharyngitisInfections and infestations5/17210/171
DiarrhoeaGastrointestinal disorders9/1728/171

Baseline characteristics

The Baseline Characteristics refers to the Safety Set which included all randomized subjects who took at least 1 dose of study medication.

Age, Categorical
Age, Categorical(Participants)PlaceboLacosamideTotal Title
<=18 years172171343
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)PlaceboLacosamideTotal Title
Mean10.9 ± 3.510.5 ± 3.610.7 ± 3.5
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboLacosamideTotal Title
Female7380153
Male9991190
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboLacosamideTotal Title
American Indian or Alaska Native101
Asian352560
Black or African American123
White129138267
Other/Mixed6612
08

Study locations

118 sites
  • 127
    Boulder, Colorado, United States
  • 105
    Orlando, Florida, United States
  • 117
    Tampa, Florida, United States
  • 103
    Atlanta, Georgia, United States
  • 124
    Lexington, Kentucky, United States
  • 112
    Louisville, Kentucky, United States
  • 121
    Shreveport, Louisiana, United States
  • 115
    Las Vegas, Nevada, United States
  • 102
    Charlotte, North Carolina, United States
  • 640
    Eugene, Oregon, United States
  • 122
    Dallas, Texas, United States
  • 101
    Tomball, Texas, United States
  • 114
    Seattle, Washington, United States
  • 143
    Buenos Aires, Argentina
  • 142
    Cordoba, Argentina
  • 200
    Heidelberg West, Australia
  • 203
    Herston, Australia
  • 205
    South Brisbane, Australia
  • 304
    Brussels, Belgium
  • 310
    Sofia, Bulgaria
  • 312
    Sofia, Bulgaria
  • 172
    Floridablanca, Colombia
  • 171
    Medellin, Colombia
  • 613
    Osijek, Croatia
  • 610
    Rijeka, Croatia
  • 612
    Zagreb, Croatia
  • 321
    Hradec Kralove, Czechia
  • 320
    Ostrava-Poruba, Czechia
  • 322
    Praha 4, Czechia
  • 323
    Praha 5, Czechia
  • 331
    Tallinn, Estonia
  • 330
    Tartu, Estonia
  • 620
    Tbilisi, Georgia
  • 621
    Tbilisi, Georgia
  • 622
    Tbilisi, Georgia
  • 623
    Tbilisi, Georgia
  • 361
    Budapest, Hungary
  • 362
    Budapest, Hungary
  • 363
    Budapest, Hungary
  • 364
    Budapest, Hungary
  • 360
    Debrecen, Hungary
  • 367
    Miskolc, Hungary
  • 366
    Pecs, Hungary
  • 370
    Holon, Israel
  • 371
    Kfar Saba, Israel
  • 374
    Petach Tikva, Israel
  • 372
    Tel Aviv, Israel
  • 384
    Bologna, Italy
  • 388
    Florence, Italy
  • 387
    Genova, Italy
  • 380
    Mantova, Italy
  • 381
    Milano, Italy
  • 393
    Padova, Italy
  • 383
    Roma, Italy
  • 392
    Roma, Italy
  • 386
    Verona, Italy
  • 211
    Daegu, Korea, Republic of
  • 210
    Seoul, Korea, Republic of
  • 212
    Seoul, Korea, Republic of
  • 213
    Seoul, Korea, Republic of
  • 215
    Seoul, Korea, Republic of
  • 400
    Riga, Latvia
  • 402
    Valmiera, Latvia
  • 411
    Kaunas, Lithuania
  • 569
    Culiacan, Mexico
  • 563
    Guadalajara, Mexico
  • 568
    Monterrey, Mexico
  • 660
    Podgorica, Montenegro
  • 433
    Gdansk, Poland
  • 432
    Katowice, Poland
  • 420
    Kielce, Poland
  • 422
    Krakow, Poland
  • 431
    Krakow, Poland
  • 423
    Poznan, Poland
  • 425
    Poznan, Poland
  • 421
    Szczecin, Poland
  • 429
    Tyniec Maly, Poland
  • 430
    Warszawa, Poland
  • 428
    Wroclaw, Poland
  • 574
    Bucuresti, Romania
  • 572
    Cluj-Napoca, Romania
  • 576
    Sibiu, Romania
  • 580
    Suceava, Romania
  • 570
    Timisoara, Romania
  • 577
    Timisoara, Romania
  • 443
    Kazan, Russian Federation
  • 444
    Kazan, Russian Federation
  • 442
    Moscow, Russian Federation
  • 449
    Moscow, Russian Federation
  • 440
    Smolensk, Russian Federation
  • 441
    St. Petersburg, Russian Federation
  • 446
    St. Petersburg, Russian Federation
  • 447
    Voronezh, Russian Federation
  • 464
    Belgrade, Serbia
  • 460
    Kragujevac, Serbia
  • 461
    Novi Beograd, Serbia
  • 462
    Novi Sad, Serbia
  • 463
    Novi Sad, Serbia
  • 470
    Bardejov, Slovakia
  • 473
    Nitra, Slovakia

Showing the first 100 of 118 sites across 28 countries. Choose a country and city above to see the rest.

09

References and documents

Publications

  • Johnson ME, McClung C, Bozorg AM. Analyses of seizure responses supportive of a novel trial design to assess efficacy of antiepileptic drugs in infants and young children with epilepsy: Post hoc analyses of pediatric levetiracetam and lacosamide trials. Epilepsia Open. 2021 Jun;6(2):359-368. doi: 10.1002/epi4.12482. Epub 2021 May 3. PubMed 34033237 ↗
  • Babar RK, Bresnahan R, Gillespie CS, Michael BD. Lacosamide add-on therapy for focal epilepsy. Cochrane Database Syst Rev. 2021 May 17;5(5):CD008841. doi: 10.1002/14651858.CD008841.pub3. PubMed 33998660 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2013, a primary completion of Jan 2017 and a completion of Jan 2017. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2018, 1 year 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2013
First posted
Aug 13, 2013
Start
Aug 29, 2013
Primary completionActual
Jan 24, 2017
CompletionActual
Jan 24, 2017
Results first posted
Mar 19, 2018
Last update
Jul 18, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01921205
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Aug 13, 2013
Start date
Aug 29, 2013
Primary completion
Jan 24, 2017
Completion
Jan 24, 2017
Results posted
Mar 19, 2018
Last update
Jul 18, 2018

Study contacts

UCB Cares
study director · +1 877 822 9493

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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