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

Completed · Phase 3 · Has a placebo group

Conditions studied: Epilepsy With Partial-onset Seizures

In brief

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.

Key facts

Study ID

NCT02477839

Run by

UCB BIOSCIENCES, Inc.

People needed

255

Starts

2015-06-05

Expected to finish

2020-05-28

Last updated by the study team

2021-07-01

Who can join

Age: 0 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

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 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

Where it is running

• Sp0967 117 — Tampa, Florida, United States
• Sp0967 115 — Henderson, Nevada, United States
• Sp0967 120 — Lebanon, New Hampshire, United States
• Sp0967 129 — Dallas, Texas, United States
• Sp0967 630 — San Antonio, Texas, United States
• Sp0967 643 — San Antonio, Texas, 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 638 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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