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

October 4, 2022 updated by: Taisho Pharmaceutical Co., Ltd.

A Phase II, Double-blind, Parallel-group Comparative Study 2 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka And Other Japanese City, Japan
        • Taisho Pharmaceutical Co., Ltd selected site
  • Korea, Republic of
      • Seoul And Other Korean City, Korea, Republic of
        • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Orally taken once daily for 3 weeks
Experimental: TS-091 5mg
Drug: TS-091 5mg
Orally taken once daily for 3 weeks
Experimental: TS-091 10mg
Drug: TS-091 10mg
Orally taken once daily for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean sleep latency in maintenance of wakefulness test
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Total score on the epworth sleepiness scale
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taisho Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2017

Primary Completion (Actual)

December 13, 2018

Study Completion (Actual)

August 8, 2019

Study Registration Dates

First Submitted

August 28, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (Actual)

August 30, 2017

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TS091-1701
  • JapicCTI-173689 (Other Identifier: JapicCTI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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