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

Phase 2

Completed

• Conditions: Narcolepsy
• Interventions: Drug: TS-091 10mg; Drug: Placebo; Drug: TS-091 5mg

• Registration Number: NCT03267303
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-30
• Study Start: 2017-10-31
• Primary Completion: 2018-12-13
• Study Completion: 2019-08-08
• Status Verified: 2019-10
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TS-091 10mg	TS-091 10mg	-
Placebo	Placebo	-
TS-091 5mg	TS-091 5mg	-

Primary Outcome Measures

Name	Time	Method
Mean sleep latency in maintenance of wakefulness test	3 weeks

Secondary Outcome Measures

Name	Time	Method
Total score on the epworth sleepiness scale	3 weeks

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇰🇷 Seoul and other Korean city, Korea, Republic of