Lacosamide in childhood-results of a retrospective analysis

Subject: Effectiveness and toleration of Lacosamide (LCM) in children with epilepsy younger than 16 years.

Methods: A total of 110 children undergoing treatment with LCM were selected from 10 epilepsy outpatient clinics in Germany and data were evaluated for a retrospective analysis of the above subject.

Results: There were 61 boys in total: range of age at onset of LCM treatment: 3 months to 15.3 years, with median age being 9.1 years. There were 49 girls in total: range of age at onset of LCM treatment: 3 months to 15.9 years, with median age being 10.2 years. The following forms of epilepsy were present: symptomatic focal (n = 56); LGS (n = 13); GM (n = 8); CSWS (n = 6); metabolic disorder (n = 5); chromosome defect (n = 9); Doose syndrome (n = 1); BECTS (n = 1); absence epilepsy (n = 1); focal motor (n = 1); and non-classifiable (n = 10). All children had previously been treated unsuccessfully with all AED as a monotherapy or combination therapy. LCM initial dosage: 0.5 to 8 mg/kg body weight (bw), with 3.25 mg/kg bw on average. Dosage increase: dosage was increased weekly by the amount of the initial dosage (2 to 30 days). LCM final dosage: 4 to 20 mg/kg bw, with 9.6 mg/kg bw on average.

Side effects: 73 children tolerated the LCM therapy at the described dosages with no side effects; the remaining children showed no specific conspicuous side effects.

An ECG conducted before (n = 45) and during LCM therapy (n = 34) was normal.

Comedication: differed considerably; comedication acting on sodium channels: n = 78. 10 children received LCM as a monotherapy; the comedication was reduced for 25 children and at least one AED was discontinued for 36 children.

Therapy effect: 26 children were seizure free (24.3%); 75% seizure reduction in 14 children (13.0%); 50% seizure reduction in 21 children (19.6%); 32 children experienced no benefit (29.9%). The EEG was normalized in 11/110 children, 29 improved, and 67 children showed no change on the EEG.

Seizure-free children (n = 26): symptomatic focal epilepsy (n = 11), the remaining children different epilepsy syndromes. 6 seizure-free children had an LCM serum level of 2.3 to 18.8µgr/mL (average: 10.3 µg/mL).

Comedication: Primary monotherapy (n = 3); 10 children undergoing combination therapy received an additional AED acting on the sodium channels (OXC, LTG, DPH).

Summary: LCM is also very well tolerated by children younger than 16 years of age both in monotherapy and in combination therapy. 24.3% of our group were subsequently without seizures, 13% showed a seizure reduction of 75% on LCM. The therapeutic effect appears to be enhanced without increasing side effects when LCM is combined with another AED affecting sodium channels.