Clobazam is a 1,5-benzodiazepine that potentiates the inhibitory action of gamma-aminobutyric acid (GABA) by binding to GABA-A receptors 5,6.
The prospective, double-blind, placebo controlled study enrolled 238 patients diagnosed with LGS who were randomised to receive one of three different dosages of clobazam or placebo.
The study results revealed that clobazam met its primary efficacy endpoint and several key secondary endpoints.
Data from the study’s primary endpoint revealed that the high (1.0 mg/kg/day) and medium (0.5 mg/kg/day) dosages of clobazam, compared to placebo, met a statistically significant reduction in the average weekly rate of drop seizures from the 4-week baseline period compared to the 12-week maintenance period.
Patients receiving high-dosage clobazam experienced a mean decrease in average weekly rate of drop seizures of 68.3%, compared to 49.4% for those receiving medium-dosage clobazam.
Lundbeck Global Regulatory Affairs vice president Timothy Cunniff said the company makes several treatment options available in the US for people affected by epilepsy, and the development of clobazam for those with LGS represents their ongoing commitment to making a difference in the lives of those affected by rare and challenging seizure disorders.
"We are encouraged by these phase III results and look forward to submitting an NDA very soon for clobazam," Cunniff said.