Phase 3 study of clobazam for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS)

Lundbeck presented positive data from its Phase 3 study to determine the efficacy and safety profiles of the investigational compound clobazam as adjunctive therapy in treating seizures associated with Lennox-Gastaut syndrome (LGS). This double-blind, placebo controlled study randomized 238 patients diagnosed with LGS to one of three different dosages of clobazam or placebo. In the study, clobazam met its primary efficacy endpoint showing that high (1.0 mg/kg/day; N=49) and medium (0.5 mg/kg/day; N=58) dosages of clobazam, evaluated versus placebo (N=57), met a robust statistically significant (p≤0.01) reduction in the average weekly rate of drop seizures from the 4-week baseline period compared to the 12-week maintenance period. Patients in the high-dosage clobazam group achieved a mean decrease in average weekly rate of drop seizures of 68.3 percent (p<0.0001 vs. placebo) while those in the medium-dosage arm had an average decrease of 49.4 percent (p=0.0015 vs. placebo).

A secondary endpoint of the study was responder rates. For each group treated with one of the three different dosages of clobazam, the percentage of patients with a decrease in average weekly rate of drop seizures of ≥25%, ≥50%, ≥75% or 100% from baseline to the maintenance period was compared to placebo. Among patients in the high-dosage arm, 77.6% had a 50% or greater reduction (p<0.01); 63.3% had a 75% or greater reduction (p<0.01); and 24.5% achieved 100% reduction. Among patients in the medium-dosage arm, 58.6% had a 50% or greater reduction (p<0.05); 37.9% had a 75% or greater reduction (p<0.01); and 12.1% achieved 100% reduction.

Clobazam is a 1,5-benzodiazepine that potentiates the inhibitory action of gamma-aminobutyric acid (GABA) by binding to GABA-A receptors.

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