Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
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
2 other identifiers
interventional
404
27 countries
115
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2013
Typical duration for phase_3
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2013
CompletedFirst Posted
Study publicly available on registry
August 13, 2013
CompletedStudy Start
First participant enrolled
August 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2017
CompletedResults Posted
Study results publicly available
March 19, 2018
CompletedJuly 18, 2018
March 1, 2018
3.4 years
August 8, 2013
January 23, 2018
June 21, 2018
Conditions
Keywords
Outcome Measures
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.
Baseline to Week 16 (or last value on treatment)
Secondary Outcomes (11)
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
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 End of Maintenance Period
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)
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)
Baseline to Week 16 (or last value on treatment)
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)
Baseline to Week 16 (or last value on treatment)
- +6 more secondary outcomes
Study Arms (2)
Lacosamide
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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)
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)
Eligibility Criteria
You may qualify if:
- 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 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
You may not qualify if:
- 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 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (118)
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
Córdoba, 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
Medellín, Colombia
613
Osijek, Croatia
610
Rijeka, Croatia
612
Zagreb, Croatia
321
Hradec Králové, Czechia
320
Ostrava-Poruba, Czechia
322
Prague, Czechia
323
Prague, 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
Pécs, Hungary
370
Holon, Israel
371
Kfar Saba, Israel
374
Petah Tikva, Israel
372
Tel Aviv, Israel
384
Bologna, Italy
388
Florence, Italy
387
Genova, Italy
380
Mantova, Italy
381
Milan, Italy
393
Padua, Italy
383
Roma, Italy
392
Roma, Italy
386
Verona, Italy
400
Riga, Latvia
402
Valmiera, Latvia
411
Kaunas, Lithuania
569
Culiacán, 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 Mały, Poland
430
Warsaw, Poland
428
Wroclaw, Poland
574
Bucharest, Romania
572
Cluj-Napoca, Romania
576
Sibiu, Romania
580
Suceava, Romania
570
Timișoara, Romania
577
Timișoara, Romania
443
Kazan', Russia
444
Kazan', Russia
442
Moscow, Russia
449
Moscow, Russia
441
Saint Petersburg, Russia
446
Saint Petersburg, Russia
440
Smolensk, Russia
447
Voronezh, Russia
464
Belgrade, Serbia
460
Kragujevac, Serbia
461
New Belgrade, Serbia
462
Novi Sad, Serbia
463
Novi Sad, Serbia
470
Bardejov, Slovakia
473
Nitra, Slovakia
472
Nové Zámky, Slovakia
670
Ljubljana, Slovenia
211
Daegu, South Korea
210
Seoul, South Korea
212
Seoul, South Korea
213
Seoul, South Korea
215
Seoul, South Korea
220
Changhua, Taiwan
222
Taichung, Taiwan
224
Taipei, Taiwan
232
Bangkok, Thailand
236
Bangkoknoi, Thailand
231
Muang, Thailand
233
Muang, Thailand
235
Pathumwan, Thailand
230
Ratchathewi, Thailand
602
Dnipropetrovsk, Ukraine
606
Kiev, Ukraine
682
Uzhhorod, Ukraine
603
Vinnitsa, Ukraine
514
Birmingham, United Kingdom
515
Birmingham, United Kingdom
511
Leeds, United Kingdom
Related Publications (3)
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.
PMID: 34033237DERIVEDBabar 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.
PMID: 33998660DERIVEDFarkas V, Steinborn B, Flamini JR, Zhang Y, Yuen N, Borghs S, Bozorg A, Daniels T, Martin P, Carney HC, Dimova S, Scheffer IE; SP0969 Study Group. Efficacy and tolerability of adjunctive lacosamide in pediatric patients with focal seizures. Neurology. 2019 Sep 17;93(12):e1212-e1226. doi: 10.1212/WNL.0000000000008126. Epub 2019 Aug 28.
PMID: 31462582DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 877 822 9493
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 8, 2013
First Posted
August 13, 2013
Study Start
August 29, 2013
Primary Completion
January 24, 2017
Study Completion
January 24, 2017
Last Updated
July 18, 2018
Results First Posted
March 19, 2018
Record last verified: 2018-03