Baseline demographics and epilepsy characteristics (SS)
| Placebo (n=121) | Lacosamide (n=121) | |
| Patient demographics | ||
| Age, mean (SD), years | 27.6 (12.5) | 27.8 (13.1) |
| <18 years, n (%) | 25 (20.7) | 24 (19.8) |
| ≥18 to <65 years, n (%) | 95 (78.5) | 96 (79.3) |
| ≥65 years, n (%) | 1 (0.8) | 1 (0.8) |
| Female, n (%) | 76 (62.8) | 66 (54.5) |
| Epilepsy characteristics | ||
| Time since first diagnosis, mean (SD), years | 15.4 (13.0) | 15.5 (13.1) |
| Median (range), years | 11.3 (0.5 to 60.7) | 11.4 (0.8 to 64.9) |
| Age at diagnosis, mean (SD), years | 12.9 (5.9) | 12.9 (6.8) |
| PGTCS frequency per 28 days during combined baseline, median (range) | 1.24 (0.7 to 19.4) | 1.25 (0.3 to 12.3) |
| Seizure classification history at any time before trial entry*, n (%) | ||
| Any partial-onset seizures (focal seizures) | 0 | 1 (0.8)† |
| Simple partial (focal aware) | 0 | 1 (0.8)† |
| Any generalised seizures | 121 (100) | 121 (100) |
| Absence | 41 (33.9) | 49 (40.5) |
| Atypical absence | 2 (1.7) | 2 (1.7) |
| Myoclonic | 48 (39.7) | 46 (38.0) |
| Clonic | 2 (1.7) | 3 (2.5) |
| Tonic | 1 (0.8) | 2 (1.7) |
| Tonic-clonic | 121 (100) | 120 (99.2)† |
| Atonic | 3 (2.5) | 2 (1.7) |
| Unclassified epileptic seizures | 0 | 2 (1.7) |
| No of prior AEDs and benzodiazepines‡, n (%) | ||
| 0 | 70 (57.9) | 63 (52.1) |
| 1–3 | 37 (30.6) | 47 (38.8) |
| 4–6 | 13 (10.7) | 9 (7.4) |
| ≥7 | 1 (0.8) | 2 (1.7) |
| No of concomitant AEDs and benzodiazepines at trial entry§, n (%) | ||
| 1 | 44 (36.4) | 35 (28.9) |
| 2 | 55 (45.5) | 62 (51.2) |
| ≥3 | 22 (18.2) | 23 (19.0) |
| Concomitant AEDs and benzodiazepines taken during the treatment period by ≥5% of all patients, n (%) | ||
| Valproate | 68 (56.2) | 59 (48.8) |
| Levetiracetam | 48 (39.7) | 56 (46.3) |
| Lamotrigine | 37 (30.6) | 36 (29.8) |
| Topiramate | 15 (12.4) | 16 (13.2) |
| Clonazepam | 16 (13.2) | 12 (9.9) |
| Clobazam | 13 (10.7) | 9 (7.4) |
| Zonisamide | 7 (5.8) | 7 (5.8) |
| Carbamazepine | 5 (4.1) | 9 (7.4) |
| Ongoing comorbid conditions at screening visit, n (%) | ||
| Patients with at least one ongoing medical condition | 75 (62.0) | 69 (57.0) |
| Medical conditions in ≥5% of all patients | ||
| Headache | 9 (7.4) | 13 (10.7) |
| Depression | 8 (6.6) | 12 (9.9) |
| Migraine | 8 (6.6) | 7 (5.8) |
| Obesity | 8 (6.6) | 5 (4.1) |
| Anxiety | 4 (3.3) | 8 (6.6) |
| Back pain | 5 (4.1) | 7 (5.8) |
*Patients could have more than one response in a classification level and/or category; seizure types are listed per the trial protocol (International League Against Epilepsy 1981 classification32) with the newer terminology33 provided in parentheses.
†One patient had a history of partial-onset seizures and was excluded from the per-protocol set.
‡AEDs stopped at least 28 days before visit 1.
§Number of concomitant AEDs and benzodiazepines at trial entry were unknown for one patient in the lacosamide group.
AED, antiepileptic drug; PGTCS, primary generalised tonic-clonic seizure; SS, safety set.