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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03267303
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : November 29, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Narcolepsy Drug: TS-091 5mg Drug: TS-091 10mg Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients With Narcolepsy
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Placebo Comparator: Placebo Drug: Placebo
Orally taken once daily for 3 weeks

Outcome Measures

Primary Outcome Measures :
  1. Mean sleep latency in maintenance of wakefulness test [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Total score on the epworth sleepiness scale [ Time Frame: 3 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267303

Contact: Taisho Pharmaceutical Co., Ltd +81-3-3985-1413 clinical-trials_CTG@so.taisho.co.jp

Taisho Pharmaceutical Co., Ltd selected site Recruiting
Osaka And Other Japanese City, Japan
Sponsors and Collaborators
Taisho Pharmaceutical Co., Ltd.
Study Director: Shigeru Okuyama Taisho Pharmaceutical Co., Ltd.
More Information

Responsible Party: Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03267303     History of Changes
Other Study ID Numbers: TS091-1701
JapicCTI-173689 ( Other Identifier: JapicCTI )
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taisho Pharmaceutical Co., Ltd.:

Additional relevant MeSH terms:
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders