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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01921205
• Date of registration: 08/08/2013
• Prospective Registration: Yes
• Primary sponsor: UCB Pharma
• Public title: Study to Investigate Lacosamide as Add-on Therapy in Subjects =4 Years to <17 Years of Age With Partial Onset Seizures
• Scientific title: A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy =4 Years to <17 Years of Age With Partial Onset Seizures
• Date of first enrolment: August 29, 2013
• Target sample size: 404
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01921205
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Colombia, Croatia, Czech Republic, Czechia, Estonia, France, Georgia, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Montenegro, Poland, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: UCB Cares
• Affiliation: [phone]

Key inclusion & exclusion criteria

Inclusion Criteria:

- An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
written Informed Consent 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:

- 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 investigational 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 hypersensitivity to any component of the IMP or has ever received
LCM

- Female subject who is pregnant or nursing, and/or a female subject of childbearing
potential who is not surgically sterile or does not practice 1 highly effective method
of contraception (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 alanine aminotransferase (ALT), aspartate aminotransferase (AST), or
total bilirubin level =2 times the upper limit of normal (ULN), or creatinine
clearance less than 30 mL/min

- 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]
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 a


Age minimum: 4 Years
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Lacosamide

Other: Placebo

Primary Outcome(s)

Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period [Time Frame: Baseline to Week 16 (or last value on treatment)]

Secondary Outcome(s)

Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures [Time Frame: Baseline to Week 16 (or last value on treatment)]

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) [Time Frame: Baseline to Week 16 (or last value on treatment)]

Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures [Time Frame: Baseline to Week 16 (or last value on treatment)]

Proportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period [Time Frame: Week 7 to Week 16]

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 [Time Frame: Baseline to Week 16 (or last value on treatment)]

Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures [Time Frame: Baseline to Week 16 (or last value on treatment)]

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) [Time Frame: Baseline to Week 16 (or last value on treatment)]

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 [Time Frame: Baseline to Week 16 (or last value on treatment)]

Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) [Time Frame: Baseline to Week 16 (or last value on treatment)]

Proportion of Subjects Who Achieved "Seizure Free" Status (Yes/no) for Subjects Who Completed the Maintenance Period [Time Frame: Week 7 to Week 16]

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) [Time Frame: Baseline to Week 16 (or last value on treatment)]

Secondary ID(s)

2012-004996-38

SP0969

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/03/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01921205