Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years 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 >=1 Month to <4 Years of Age With Partial-Onset Seizures
2 other identifiers
interventional
255
26 countries
88
Brief 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.
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 Jun 2015
Longer than P75 for phase_3
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2015
CompletedStudy Start
First participant enrolled
June 5, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2020
CompletedResults Posted
Study results publicly available
July 1, 2021
CompletedJuly 1, 2021
June 1, 2021
5 years
May 13, 2015
May 27, 2021
June 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days)
Secondary Outcomes (9)
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
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
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
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
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
End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
- +4 more secondary outcomes
Study Arms (2)
Lacosamide
EXPERIMENTALLacosamide syrup 8 mg/kg/day to 12 mg/kg/day
Placebo
PLACEBO COMPARATORMatching placebo syrup
Interventions
Active Substance: Lacosamide Pharmaceutical Form: Syrup Concentration: 10 mg/mL Route of Administration: oral
Active Substance: Placebo Pharmaceutical Form: Syrup Concentration: N/A Route of Administration: oral
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (88)
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
Milan, Italy
Sp0967 700
Napoli, Italy
Sp0967 383
Roma, Italy
Sp0967 395
Roma, Italy
Sp0967 694
Aguascalientes, Mexico
Sp0967 561
Chihuahua City, Mexico
Sp0967 569
Culiacán, Mexico
Sp0967 693
Culiacán, Mexico
Sp0967 563
Guadalajara, Mexico
Sp0967 564
México, Mexico
Sp0967 568
Monterrey, Mexico
Sp0967 692
Monterrey, Mexico
Sp0967 650
Chisinau, Moldova
Sp0967 720
Cebu, Philippines
Sp0967 724
Cebu, Philippines
Sp0967 721
Manila, Philippines
Sp0967 723
Manila, Philippines
Sp0967 727
Quezon City, Philippines
Sp0967 422
Krakow, Poland
Sp0967 750
Lisbon, Portugal
Sp0967 581
Bucharest, Romania
Sp0967 582
Iași, Romania
Sp0967 573
Sibiu, Romania
Sp0967 577
Timișoara, Romania
Sp0967 454
Kemerovo, Russia
Sp0967 456
Nizhny Novgorod, Russia
Sp0967 452
Novosibirsk, Russia
Sp0967 453
Omsk, Russia
Sp0967 455
Perm, Russia
Sp0967 730
Smolensk, Russia
Sp0967 458
Tomsk, Russia
Sp0967 459
Ulyanovsk, Russia
Sp0967 450
Yekaterinburg, Russia
Sp0967 461
Belgrade, Serbia
Sp0967 464
Belgrade, Serbia
Sp0967 463
Novi Sad, Serbia
Sp0967 474
Bratislava, Slovakia
Sp0967 212
Seoul, South Korea
Sp0967 215
Seoul, South Korea
Sp0967 224
Taipei, Taiwan
Sp0967 237
Bangkok, Thailand
Sp0967 235
Pathum Wan, Thailand
Sp0967 602
Dnipro, Ukraine
Sp0967 609
Dnipro, Ukraine
Sp0967 681
Ivano-Frankivsk, Ukraine
Sp0967 600
Kiev, Ukraine
Sp0967 606
Kiev, Ukraine
Sp0967 682
Uzhhorod, Ukraine
Sp0967 603
Vinnytsia, Ukraine
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 (UCB)
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
May 13, 2015
First Posted
June 23, 2015
Study Start
June 5, 2015
Primary Completion
May 28, 2020
Study Completion
May 28, 2020
Last Updated
July 1, 2021
Results First Posted
July 1, 2021
Record last verified: 2021-06