Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures

Phase 3 Completed 255 enrolled UCB BIOSCIENCES, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2015-06-05
Primary completion: 2020-05-28
Completion: 2020-05-28

Outcome

Missed primary endpoint

paper Percentage reduction in ADF of focal seizures for lacosamide (116 patients) versus placebo (120 patients) was 3.2% (95% confidence interval = -13.6 to 17.5, p = 0.69). PMID 38375995 ↗

paper Adjunctive lacosamide did not show superior efficacy versus placebo in young children with focal seizures. PMID 38375995 ↗

Publications

Makedonska I, Ng YT, Beller C, Bozorg A, Csikos J, McClung C, Moeltgen H, Farkas MK; SP0967 Study Group. Efficacy and tolerability of adjunctive lacosamide in patients aged <4 years with focal seizures. Ann Clin Transl Neurol. 2024 Mar;11(3):768-779. doi: 10.1002/acn3.52004. Epub 2024 Feb 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lacosamide	Other / unclassified	8 mg/kg	Oral
Subject	Lacosamide	Other / unclassified	12 mg/kg	Oral