Clinical Trials Resource Center

New Medical Therapies™

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.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.