Minerva Neurosciences Inc, a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, provided a year-end update on clinical trials testing MIN-202 for insomnia disorder.
Patient enrollment has been completed in two trials with MIN-202, under joint development with Janssen Pharmaceutica NV. These include a Phase IIa trial in insomnia disorder and a Phase Ib trial in adjunctive treatment of MDD.
The Phase IIa trial in insomnia disorder is a randomized, placebo-controlled double-blind study to evaluate treatment with MIN-202 in 26 patients with insomnia disorder without psychiatric comorbidity. The primary endpoint is sleep efficiency as measured by polysomnography, with secondary endpoints including additional assessments of sleep, mood, and cognition, as well as safety.
The Phase Ib trial in adjunctive treatment of major depressive disorder (MDD) is a randomized, diphenhydramine- and placebo-controlled double-blind trial to evaluate treatment with MIN-202 in 48 patients with MDD. The primary endpoint is safety, and secondary endpoints include assessments of depressive symptomology, cognition, and sleep.