Table 1.
Clobazam as add on therapy in refractory pediatric epilepsy.
| Study | Trial design | Participants and included diagnoses | Dosage | Results |
|---|---|---|---|---|
| Conry et al.6 | Phase II, multi-center, randomized, double-blind, dose-ranging | 68 patients; 2-26 years; LGS | 0.25 mg/kg/day, or 1.0 mg/kg/day | 0.25 mg/kg/day: 38% of patients had a >50% decrease in drop seizure rates; 1.0 mg/kg/day: 83% of patients had a ≥50% decrease in drop seizure rates |
| Conry et al.7 | Phase III, multi-center, randomized, double-blind, dose-ranging, placebo-controlled | 238 patients; 2-54 years; LGS | 0.25 mg/kg/day, 0.5 mg/kg/day, or 1.0 mg/kg/day | 0.5 mg/kg/day: 58% of patients had a >50% decrease in drop seizure rates; 1.0 mg/kg/day: 77% of patients had a >50% decrease in drop seizure rates |
| Da Silveira et al.11 | Retrospective | 100 patients; 1-18 years; refractory focal epilepsy | 5-60 mg/day | 33% of patients had a ≥75% decrease in seizure rates |
| Farrell12 | Open-label, prospective | 50 patients, 33 with LGS2; 16 years; refractory epilepsy | 5-40 mg/day | 54% of patients had a ≥50% decrease in seizure rates |
| Jan and Shaabat13 | Open-label, prospective | 31 patients, 14 with LGS; 2 months to 15 years intractable childhood epilepsy | 5-40 mg/day | 80% of patients had a ≥50% decrease in seizure rates |
| Kalra et al.14 | Open-label, prospective | 88 patients; 7 months to 12 years refractory epilepsy | 0.3-2.0 mg/kg/day | 85% of patients had a ≥50% decrease in seizure rates |
| Keene et al.15 | Double-blind, placebo-controlled, crossover | 21 patients; 2-19 years; refractory epilepsy | 0.25-1.0 mg/kg/day | 54% of patients had a ≥50% decrease in seizure rates |
| Munn and Farrell16 | Open-label, prospective | 115 patients, 25 with LGS; 15 months to 17 years; refractory epilepsy | 0.36-3.8 mg/kg/day | 62% of all patients had a ≥50% decrease in seizure rates; 64% of LGS patients had a ≥50% decrease in seizure rates |
| Silva et al.17 | Retrospective | 97 patients, 26 with LGS; 2 with LGS and West syndrome; 1-17 years; epileptic encephalopathy | 5-60 mg/day | 37% of patients had a ≥50% decrease in seizure rates |
| Sheth et al.18 | Open-label, prospective | 63 patients, 14 with LGS; 3-20 years; intractable epilepsy | Average 0.8 mg/kg/day | 65% of patients had ≥50% decrease in seizure rates |
| Sugap19 | Open-label, prospective | Short-term: 55 patients; 8 with LGS; long-term: 31 patients, 4 with LGS; refractory epilepsy | 0.28-1.25 mg/kg/day | Short term: 71% of all patients and 62% of LGS patients had a ≥50% decrease in seizure rates; Long-term: 81% of all patients and 50% of LGS patients had a >50% decrease in seizure rates |
| Vadja et al.20 | Open-label, prospective or double-blind, placebo-controlled, crossover | 14 patients,*7 with LGS; 6-38 years; refractory epilepsy | 15-60 mg/day | 40% of patients had a ≥50% decrease in seizure rates |
LGS, Lennox-Gastaut syndrome
*results were not reported for 4 patients.