Adults 1 Month to 17, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)Primary· From Week 0 to the End of Safety Follow-Up (up to Week 104)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days
Group
Value
95% CI
Lacosamide (All Subjects)
77.2
Percentage of Participants With Serious TEAEsPrimary· From Week 0 to the End of Safety Follow-Up (up to Week 104)
A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatien
Group
Value
95% CI
Lacosamide (All Subjects)
20.6
Percentage of Participants With TEAEs Leading to Study DiscontinuationPrimary· From Week 0 to the End of Safety Follow-Up (up to Week 104)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Group
Value
95% CI
Lacosamide (All Subjects)
4.1
Percentage of Seizure-free Days During the StudySecondary· From Week 0 to End of Treatment (up to Week 96)
The number of seizure-free days was the total number of days within an interval for which daily diary data were available and no seizures were reported. The percentage of seizure-free days was computed as 100 times the number of seizure-free days in the interval divided by the number of days in the interval for which daily diary data were available. Percentage of seizure-free days was measured using data obtained from participant diaries from EP0034 and is presented for the overall Treatment only.
Group
Value
95% CI
Lacosamide (All Subjects)
66.96
± 36.18
Adverse events — posted to ClinicalTrials.gov
Time frame: From Week 0 to the End of Safety Follow-Up (up to Week 104).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT06969417 — Comparative Efficacy of Pregabalin and Lacosamide in Patients With Herpes Zoster and Post Herpetic Neuralgia
· NA
· recruiting
NCT05603702 — STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis
· Phase 1
· recruiting
NCT05510856 — Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Indu
· Phase 4
· completed
NCT05291455 — Lacosamide in Neonatal Status Epilepticus
· Phase 3
· unknown
NCT04627285 — A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034)
· Phase 3
· completed
Other recruiting trials for Epilepsy
Currently open trials in the same condition.
NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy
· EARLY_PHASE1
· recruiting
NCT07224191 — Hippocampal Oscillations During Exploration
· NA
· recruiting
NCT07219407 — A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
· Phase 2
· recruiting
NCT07417280 — LIFUS For Neurological Disorders
· NA
· recruiting
NCT07490769 — Levetiracetam Three Times Daily in Epilepsy
· Phase 3
· recruiting
Other UCB BIOSCIENCES, Inc. trials
Trials by the same sponsor.
NCT07503444 — A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome
· Phase 3
· not yet recruiting
NCT06679413 — A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants
· Phase 1
· completed
NCT06118255 — A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less
· Phase 3
· active not recruiting
NCT03845712 — An Open-Label Study of Continuation Treatment With Combination Pyrimidine Nucleosides in Patients With TK2 Deficiency
· Phase 2
· active not recruiting
NCT02710890 — Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.
· Phase 2, PHASE3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB BIOSCIENCES, Inc.
Last refreshed: 25 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01964560.