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Completed

NCT Number: NCT03267303

A Study to Evaluate the Safety and Efficacy 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.

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Key information

Conditions

Narcolepsy Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

16 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Taisho Pharmaceutical Co., Ltd selected site, Osaka and Other Japanese City, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

TS-091 5mg

Drug

Orally taken once daily for 3 weeks

TS-091 10mg

Drug

Orally taken once daily for 3 weeks

Placebo

Drug

Orally taken once daily for 3 weeks

Primary outcomes

  1. Mean sleep latency in maintenance of wakefulness test

    Time frame: 3 weeks

Secondary outcomes

  1. Total score on the epworth sleepiness scale

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 30, 2017
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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