A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures.
CompletedPhase 2Results postedLast updated 7 May 2019
What this trial tests
Phase 2 trial testing Lacosamide in Epilepsy in 55 participants. Completed in 10 April 2018.
Adults 1 Month to 18, 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.
Mean Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 to Visit 6Primary· From Baseline (Day 1) to Visit 6 (Week 6)
The mean change in the count of generalized spike-wave discharges was presented. Visit 6 (Week 6) was the End of the Titration Period.
Group
Value
95% CI
Lacosamide 1 Month - <4 Years SS
-4.55
± 257.32
Lacosamide 4 Years - <2 Years SS
-166.22
± 447.80
Lacosamide 12 Years - <18 Years SS
-203.12
± 432.42
Mean Change in Days With Any Generalized Seizures (Absence, Myoclonic, Clonic, Tonic, Tonic-clonic, Atonic, Partial Evolving to Secondarily Generalized) Per 28 Days From the Baseline Period to the Maintenance Period (Approximately 24 Weeks)Primary· Baseline Period to the Maintenance Period (approximately 24 weeks)
The mean change in the count of days with generalized seizures was presented.
Group
Value
95% CI
Lacosamide 1 Month - <4 Years SS
0.50
± 6.63
Lacosamide 4 Years - <2 Years SS
-1.90
± 3.76
Lacosamide 12 Years - <18 Years SS
-3.38
± 6.42
Mean Changes in Count of 3 Hz Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory EEG From Visit 2 to Visit 6Secondary· From Baseline (Day 1) to Visit 6 (Week 6)
The mean change in the count of 3 Hertz (Hz) spike-wave discharges was presented. Visit 6 (Week 6) was the End of the Titration Period.
Group
Value
95% CI
Lacosamide 1 Month - <4 Years SS
-0.14
± 0.42
Lacosamide 4 Years - <2 Years SS
-1.60
± 9.92
Lacosamide 12 Years - <18 Years SS
0.00
± 0.00
Number of Subject Withdrawals Due to Adverse Events From Baseline to End of Study (Approximately 32 Weeks)Secondary· From Baseline to End of Study (approximately 32 weeks)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Group
Value
95% CI
Lacosamide 1 Month - <4 Years SS
0
Lacosamide 4 Years - <2 Years SS
0
Lacosamide 12 Years - <18 Years SS
3
Number of Subjects Experiencing at Least 1 Treatment-emergent Adverse Event From Baseline to End of Study (Approximately 32 Weeks)Secondary· From Baseline to End of Study (approximately 32 weeks)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Group
Value
95% CI
Lacosamide 1 Month - <4 Years SS
10
Lacosamide 4 Years - <2 Years SS
21
Lacosamide 12 Years - <18 Years SS
18
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected throughout the study (up to week 26).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
SP0966 is an exploratory study to investigate safety and efficacy of Lacosamide (LCM) in children with epilepsy syndromes associated with generalized seizures. LCM will be added to current antiepileptic treatment.
Publications & conference data
3 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 trials
Trials by the same sponsor.
NCT01921205 — Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
· Phase 3
· completed
NCT01095393 — National Data Bank for Rheumatic Disease Registry Study of Safety in Patients With Rheumatoid Arthritis Treated With Cim
· completed
NCT00350103 — A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
· Phase 3
· completed
NCT00291668 — Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease
· Phase 2
· completed
NCT00291642 — A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 9 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
Last refreshed: 7 May 2019
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/NCT01969851.