Phase 3
N=48
A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT04627285 ↗Enrolled (actual)
48
Serious AEs
14.6%
Results posted
Aug 2025
Primary outcome: Primary: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) — 42.1; 37.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lacosamide (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- UCB Biopharma SRL
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) |
42.1; 37.9 | — |
| PRIMARY Percentage of Participants Who Withdrew From Study Due to TEAEs |
0.0; 6.9 | — |
| PRIMARY Percentage of Participants Who Withdrew From Study Due to Serious Adverse Event (SAEs) |
0.0; 6.9 | — |
| PRIMARY Modal Daily Dose During the Study |
9.5; 10.0 | — |
| PRIMARY Maximum Daily Dose During the Study |
9.5; 10.1 | — |
Summary
The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).
Eligibility Criteria
Inclusion Criteria
- Participant is male or female, aged <6 years at the time of signing the Informed Consent Form (ICF)
- Participant has completed participation in NCT01964560 (EP0034) or NCT00938912 (SP848)
- Participant is expected to benefit from participation, in the opinion of the Investigator
Exclusion Criteria
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
- Participant is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
- Participant meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for NCT01964560 (EP0034) or NCT00938912 (SP848), or is experiencing an ongoing serious adverse event (SAE)
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study
Data sourced from ClinicalTrials.gov (NCT04627285). 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.