Table 1.

Summary of recent Phase II and III studies evaluating the efficacy of clobazam in patients with seizures associated with Lennox–Gastaut syndrome

Study	Design	Outcome measures	Results
OV-10027	R, DB, DR	Primary: percent change in mean weekly DS vs baseline	n=68
	Phase II	Secondary: percent change in mean weekly non-DS vs baseline	Primary: 12%±122% change (low-dose, P=0.0162), and 85%±16.8% change (high-dose, P<0.0001)
	Patients 2–60 years old 4-week baseline, 3-week titration, 4-week maintenance 0.25 mg/kg/day (low-dose) vs 1 mg/kg/day (high-dose)		Secondary: 9%±92% change (low-dose, NS), and 59%±55% change (high-dose, P<0.0001)
OV-1012 (CONTAIN)28	R, DB, DR, PC	Primary: percent change in mean weekly DS vs baseline	n=217
	Phase III	Secondary: percent change in mean weekly non-DS vs baseline, and change in mean weekly total seizures vs baseline	Primary: 41.2% change (low-dose, P=0.012), 49.4% change (medium-dose, P=0.0015), 68.3% change (high-dose, P<0.0001), and 12.1% (placebo, NS)
	Patients 2–60 years old 4-week baseline, 3-week titration, 12-week maintenance 0.25 mg/kg/day (low-dose) vs 0.5 mg/kg/day (medium-dose) vs 1 mg/kg/day (high-dose) vs placebo		Secondary: non-DS = all nonsignificant Total seizures =34.8% change (low-dose, P=0.0414), 45.3% (medium-dose, P=0.0044), 65.3% (high-dose, P<0.0001), and 9.3% (placebo, NS)

Abbreviations: R, randomized; DB, double blind; DR, dose ranging; DS, drop seizures; NS, nonsignificant; PC, placebo controlled.