Overview
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy
Status:
Completed
Completed
Trial end date:
2019-08-08
2019-08-08
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Taisho Pharmaceutical Co., Ltd.
Criteria
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)