Ergomed has completed recruitment in a phase IIa clinical trial of lorediplon in patients with insomnia disorder.
Under Ergomed's co-development agreement with Ferrer, the Phase IIa clinical trial is a double-blind, randomized, placebo-controlled cross-over, dose finding study of two oral doses of lorediplon in adult patients with insomnia disorder.
The effects of lorediplon (5 and 10 mg) are being compared to both placebo and zolpidem.
The aim of the study is to evaluate the appropriate effective dose of lorediplon, to further characterise its efficacy on sleep maintenance/sleep quality and to evaluate any next day hangover effects in adult patients with insomnia disorder. The recruitment target of at least 130 patients has been met from 11 clinical sites across three European countries. The clinical trial is expected to complete in Q4 2016 with the final results announced around the end of the year.