Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy
Lead Sponsor:
Taisho Pharmaceutical Co., Ltd.
Conditions:
Narcolepsy
Eligibility:
All Genders
16-64 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Patients diagnosed with narcolepsy type 1 or type 2 based on the International Classification of Sleep Disorders, third edition (ICSD-3) criteria
- Patients aged ≥16 to \<65 years at the time of obtaining informed consent
- Outpatients
Exclusion
- Patients with sleep disorders other than narcolepsy (e.g., sleep apnea syndrome, periodic limb movement disorder)
- Patients with organic brain diseases (including neurodegenerative diseases or cerebrovascular disorders) or epilepsy
- Patients with obstructive respiratory diseases (bronchial asthma, emphysema)
- Patients with psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia)
Key Trial Info
Start Date :
October 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2019
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03267303
Start Date
October 31 2017
End Date
August 8 2019
Last Update
February 28 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Taisho Pharmaceutical Co., Ltd selected site
Osaka and Other Japanese City, Japan
2
Taisho Pharmaceutical Co., Ltd selected site
Seoul and Other Korean City, South Korea