Table 1.
Studies of levetiracetam in infants and children with partial onset seizures
| Study | Trial design | Diagnosis | Ages | POS/total #* | Duration (mean) | Dosage (mg/kg/d) | efficacy*** |
|---|---|---|---|---|---|---|---|
| Glauser 200234 | Open-label, prospective, add-on | POS | 6–12 yr | 24/24 | 6 w titrate, 8 w eval | 20–40 | Sz free: 2 (9%) ≥50% red: 12 (52%) ≥75% red: 5 (22%) |
| Wheless 200238 | Open-label, prospective, add-on | RE | 6 mo–14 yr | 25/39** | ≤9 mo (5 mo) | 45.7 (mean) | Sz free: 8% ≥50% red: 33% |
| Tan 200437 | Retrospective, add-on | RE | <10 yr | 11/26 | 1–30 mo (8 mo) | 13–68.5 | ≥50% red: 8 (72%) |
| Grosso 200518 | Open-label, prospective, add-on | RE | 6 mo–16 yr | 53/110 | 2–20 mo (median: 7 mo) | 10–60 | Sz free: 6 (11.3%) ≤50% red: 25 (47.2%) |
| Lagae 20053 | Open-label, prospective, add-on and monotherapy | RE | 6 mo–16 yr | Add-on: 31/67Mono: 4/10 | 20 w | 12–62 (median 33) | Add-onSz free: 2 (6%) ≥50% red: 16 (51%) Monotherapy Sz free: 1 (25%) ≥50% red: 4 (100%) |
| Mandelbaum 20055 | Retrospective, add-on and monotherapy | RE | 9 mo–23 yr | 15/59 | 12 mo | 11.36–227.27 | Sz free: 5 (33%) 50%–90% red: 1 (7%) <50% red: 9 (60%) |
| Opp 20054 | Open-label, prospective, add-on | RE | <8 yr | 134/285 | 12–86 w (median: 33 w) | varied, max dose = 47.4 + 21.8 | ≥50 red: 35 (26.1%) |
| Glauser 20066 | Randomized, double-blind, placebo-controlled, add-on | POS | 4–16 yr | 198/198 | 14 w | 60 | Sz free LEV: 7 (6.9%) Placebo: 1 (1%) ≥50% red LEV: 45 (44.6%) Placebo: 19 (19.6%) |
| Coppola 200751 | Open-label, prospective, randomized, monotherapy | POS w/BECTS | 3–14 yr | 21/39 | 12–24 mo (18.5 mo) | 20 or 30 | Sz free @ 18 mo LEV: 19 (90.5%) OXC: 13 (72.2%) |
| Fountain 200724 | Open-label, prospective, add-on | POS | 4–12 yr | 21/21 | 10 w | 20–60 | ≥50% red: 9 (43%) |
| Grosso 200735 | Retrospective, add-on | RE | <4 yr | 30/81 | 3–42 mo (9 mo) | 25–62 | Sz free: 6 (20%) ≥50% red: 11 (37%) |
| Callenbach 20089 | Open-label, prospective, add-on | RE | 4–16 yr | 19/33 | 26 w | 9–53 (mean –26) | Sz free for ≥4 w: 7 ≥50% red: 11 |
| Cilio 200941 | Case series, add-on | MPSI | 3 mo, 9 mo | 2/2 | 10 mo, 16 mo | Loading: 60 mg/kg Maintain: 30 mg/kg (BID) | SE stopped within 12 h |
| Kirmani 200942 | Retrospective, add-on and monotherapy | SE/ASE | 2 mo–18 yr | 29/32** | 24–48 h | Loading: 50 mg/kg (25); 25 mg/kg (4); 60 mg/kg (2); 70 mg/kg (1) Maintain: 25 mg/kg/12 h | All responded clinically and on EEG within 25–30 min of infusion |
| Levisohn 200930 | Randomized, double-blind, placebo-controlled, add-on | POS | 4–16 yr | 98/98 | 12 w | 20–60 | Sz free LEV: 30 (46.9%) Placebo: 3 (8.8%) ≥50% red LEV: 40 (62.5%) Placebo: 14 (41.2%) |
| Pina-Garza 200910 | Randomized, double-blind, placebo-controlled, add-on | POS | 1 mo–<4 yr | 116/116 | 5 d | 40 (<6 mo); 50 (>6 mo) | ≥50% red LEV: 25 (43.1%) Placebo: 10 (19.6%) |
| Pina-Garza 201031 | Open-label, prospective, long-term add-on | POS | 1 mo–<4 yr | 152/152 | 30–48 w(41 w) | 20–80 | Sz free ≥ 24 w: 10 (7.6%) ≥50% red: 71 (53.8%) |
| Chhun 201136 | Open-label, prospective, add-on | POS, GS, CSWS | 6 mo–15 yr | 37/102 | 6 mo | 40–60 | ≥50% red @ 3 mo POS: 14 (39%) CSWS: 4 (80%) (3 sz free, 1 92% red) >50% red @ 6 mo POS: 9 (25%) CSWS: 4 (80%) |
| McTague 201243 | Open-label, prospective, acute ivadministration, add-on andmonotherapy | ARS, CSE, NCSE | 2 mo–18 yr | 27/51 | 0–18 mo | initial dose: 5–30 mg/kg Maintain: 10–25 mg/kg | Sz free: 18 (67%) ≥50% red: 5 (18.5%) |
| Schiemann-Delgado 201211 | Open-label, prospective, long-term add-on | POS | 4–16 yr | 103/103 | 48 w | 20–100 | Sz free 12 w: 31 (33.4%) Sz free 24 w: 26 (28%) Sz free 40 w: 10 (24.7%) ≥50% red: 65 (69%) |
Notes: *Because some studies included other seizure types and/or adult patients, we provide a fraction of patients under 18 with POS/total number of enrolled patients;
includes partial and partial with secondary generalization;
efficacy reports are only for subjects under 18 years old with POS.
Abbreviations: ARS, acute repetitive seizure; ASE, acute seizure exacerbation; BECTS, benign epilepsy with centrotemporal spikes; BID, twice daily; CSE, convulsive status epilepticus; CSS, continuous spike and wave activity in slow wave sleep; EEG, electroencephalography; Eval, evaluation; GS, generalized seizure; LEV, levetiracetam; Mono, monotherapy; MSI, migrating partial seizure of infancy; NCSE, non-convulsive status epilepticus; OXC, oxcarbazepine; POS, partial onset seizure; RE, refractory epilepsy; Red, reduction; SE, status epilepticus; Sz, seizure.