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NCT03267303 Clinical Trial

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

Narcolepsy Clinical Trial

Official title:
A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients With Narcolepsy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03267303
Other study ID # TS091-1701
Secondary ID JapicCTI-173689
Status Completed
Phase Phase 2
First received
Last updated
Start date October 31, 2017
Est. completion date August 8, 2019

Study information
Verified date October 2019
Source Taisho Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date August 8, 2019
Est. primary completion date December 13, 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years to 64 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• TS-091 5mg
Orally taken once daily for 3 weeks
• TS-091 10mg
Orally taken once daily for 3 weeks
• Placebo
Orally taken once daily for 3 weeks

Locations
Country Name City State
Japan Taisho Pharmaceutical Co., Ltd selected site Osaka And Other Japanese City
Korea, Republic of Taisho Pharmaceutical Co., Ltd selected site Seoul And Other Korean City

Sponsors (1)
Lead Sponsor Collaborator
Taisho Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean sleep latency in maintenance of wakefulness test 3 weeks
Secondary Total score on the epworth sleepiness scale 3 weeks
See also
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Completed NCT00132873 - Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy Phase 3
Completed NCT00107848 - PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Phase 3
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Enrolling by invitation NCT05113745 - A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy Phase 3
Suspended NCT04419792 - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
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