Adults 16 to 70, any sex, with Epilepsy or Partial-onset Seizures. 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.
Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study VisitPrimary· From Visit 1 (Week 0) up to approximately Week 323
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. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Group
Value
95% CI
Lacosamide (SS)
410
Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study VisitPrimary· From Visit 1 (Week 0) up to approximately Week 323
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 and led to the withdrawal of the participants from the study. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Group
Value
95% CI
Lacosamide (SS)
51
Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009Secondary· From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
The percent change from Baseline to the Treatment Period was calculated as {\[(Seizure frequency per 28 days during the Treatment Period) minus (Seizure frequency per 28 days during Baseline Period)\] divided by (Seizure frequency per 28 days during Baseline Period)} multiplied by 100. Baseline was defined as the Baseline Period of study EP0008 \[NCT01710657\].
Group
Value
95% CI
Lacosamide (FAS)
-44.47
± 55.82
Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009Secondary· From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
A responder is a subject experiencing a greater than or equal to (≥) 50 % reduction in partial-onset seizure frequency per 28 days from baseline. Baseline was defined as the Baseline Period of study EP0008 \[NCT01710657\].
Group
Value
95% CI
Lacosamide (FAS)
57.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 \[NCT01710657\]
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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 Pharma SA trials
Trials by the same sponsor.
NCT01364597 — Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy
· Phase 3
· completed
NCT00345800 — Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
· Phase 1
· completed
NCT00152503 — Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
· Phase 2
· completed
NCT00150813 — Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.
· Phase 3
· completed
NCT00152464 — Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic De
· Phase 3
· 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 Pharma SA
Last refreshed: 17 August 2021
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/NCT01832038.