Clinical Trials Resource Center

Epilepsy (Pediatric)

December 13, 2010

H. Lundbeck released positive results from a phase III trial of clobazam for the treatment of Lennox-Gastaut syndrome (LGS). This multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolled 238 subjects who were randomized to receive either placebo or low (0.25 mg/kg/day up to a maximum of 10 mg per day), medium (0.5 mg/kg/day; maximum daily dosage of 20 mg per day) or high (1.0 mg/kg/day; maximum daily dosage of 40 mg) doses clobazam for up to 23 weeks. Of the 238 randomized subjects, a total of 217 comprised the modified intent to treat (mITT) population. The primary endpoint was the reduction in the average weekly rate of drop seizures from the 4-week baseline period compared to the 12-week maintenance period. Data showed that the high and medium dosages of clobazam met this endpoint with statistical significance over placebo (p≡0.01). Subjects in the high-dosage clobazam group achieved a mean decrease in average weekly rate of drop seizures of 68.3% (p<0.0001 vs. placebo) while those in the medium-dosage arm had an average decrease of 49.4% (p≡0.0015 vs. placebo). Secondary endpoints, including responder rates and the effect of clobazam in decreasing total seizures, were also significantly improved in the high- and medium-dose clobazam arms versus placebo.

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