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

A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients with Narcolepsy

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

Inclusion Criteria:

1. Patients diagnosed with narcolepsy type 1 or type 2 based on the International Classification of Sleep Disorders, third edition (ICSD-3) criteria
2. Patients aged ≥16 to <65 years at the time of obtaining informed consent
3. Outpatients

Exclusion Criteria:

1. Patients with sleep disorders other than narcolepsy (e.g., sleep apnea syndrome, periodic limb movement disorder)
2. Patients with organic brain diseases (including neurodegenerative diseases or cerebrovascular disorders) or epilepsy
3. Patients with obstructive respiratory diseases (bronchial asthma, emphysema)
4. Patients with psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia)