Phase 3
N=255
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures
Epilepsy With Partial-onset Seizures
Bottom Line
View on ClinicalTrials.gov: NCT02477839 ↗Enrolled (actual)
255
Serious AEs
4.7%
Results posted
Jul 2021
Primary outcome: Primary: 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 — 1.44; 1.40 percent change — p==0.6895
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lacosamide (Drug); Placebo (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- UCB BIOSCIENCES, Inc.
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
1.44; 1.40 | =0.6895 |
| PRIMARY Participant Withdrawals Due to Adverse Events (AEs) During the Study |
0; 1.6 | — |
| PRIMARY 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 |
59.1; 56.3 | — |
| SECONDARY 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 |
-4.7650; -2.9427 | — |
| SECONDARY 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 |
-26.7927; -32.3564 | — |
| SECONDARY Percentage of Participants Who Achieved 'Seizure-free' Status From All Seizure Types During the End-of-Maintenance (EOM) Period Video-EEG |
15.8; 17.1 | — |
| SECONDARY Percentage of Participants Who Achieved 'Seizure-free' Status From Partial-onset Seizure Types Only During the End-of-Maintenance (EOM) Period Video-EEG |
16.7; 18.8 | — |
| SECONDARY 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 |
18.3; 18.1 | — |
| SECONDARY Percentage of Participants Experiencing a 50% to 75% 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 |
17.5; 10.3 | — |
| SECONDARY Percentage of Participants Experiencing a >75% 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 |
20.0; 31.0 | — |
| SECONDARY Percentage of Participants Experiencing no Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures (Between <25% Reduction and <25% Increase) From EOB Period Video-EEG to EOM Period Video-EEG |
28.3; 27.6 | — |
| SECONDARY Percentage of Participants Experiencing an Increase in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures of >=25% From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG |
15.0; 12.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject is male or female from >=1 month (ie, 4 weeks after full term [37 weeks gestational age]) to =1 prior EEG and >=1 magnetic resonance imaging/computerized tomography scan should be consistent with this diagnosis
- Subject weighs >=4 kg to =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
Exclusion Criteria
- 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 =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 =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
Data sourced from ClinicalTrials.gov (NCT02477839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.