A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy

Summary

The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.

Timeline

Start

2017-10-31

Primary completion

2018-12-13

Completion

2019-08-08

Outcome

Missed primary endpoint

paper although the efficacy could not be confirmed with MWT and ESS in Study 2. PMID 35193545 ↗

Publications

• Inoue Y, Uchiyama M, Umeuchi H, Onishi K, Ogo H, Kitajima I, Matsushita I, Nishino I, Uchimura N. Optimal dose determination of enerisant (TS-091) for patients with narcolepsy: two randomized, double-blind, placebo-controlled trials. BMC Psychiatry. 2022 Feb 22;22(1):141. doi: 10.1186/s12888-022-03785-7.

Drugs

Indications